Trial Outcomes & Findings for Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD). (NCT NCT01218126)
NCT ID: NCT01218126
Last Updated: 2018-02-06
Results Overview
Exercise tolerance was assessed using the 6MWD. If a participant was recorded as having used supplemental oxygen or a walking aid (including sitting down then continuing walking) or a technical problem during a 6MWD then that walk was considered as invalid; otherwise the 6MWD was considered as valid. The baseline 6MWD value was defined as the longest distance walked, for a valid walk, at Visit 2. Variability between the distances walked during the first six-minute walk test (6MWD1) and the second six-minute walk test (6MWD2) being compared was defined as: Variability = \[100 x (6MWD2 - 6MWD1)\]/6MWD1. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
604 participants
Primary outcome timeframe
Baseline (Week 0) and Week 4, 12, 24
Results posted on
2018-02-06
Participant Flow
This study was conducted from 04 November 2010 to 22 December 2011 across 65 centers worldwide. A total of 1000 participants with history of COPD exacerbations were planned to be screened and finally, 600 participants were planned to be randomized.
A total of 886 participants were screened, 282 were screen failures, remaining 604 were randomized to receive the study drug. Out of the randomized 604, 2 participants did not receive the study drug due to error in randomization.
Participant milestones
| Measure |
Placebo
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
Participants received Losmapimod 2.5 milligram (mg) tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
153
|
149
|
151
|
149
|
|
Overall Study
COMPLETED
|
129
|
127
|
127
|
114
|
|
Overall Study
NOT COMPLETED
|
24
|
22
|
24
|
35
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
Participants received Losmapimod 2.5 milligram (mg) tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
10
|
12
|
16
|
|
Overall Study
Lack of Efficacy
|
7
|
2
|
2
|
6
|
|
Overall Study
Protocol Violation
|
5
|
2
|
2
|
3
|
|
Overall Study
Protocol-defined stopping criteria
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
2
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
4
|
6
|
Baseline Characteristics
Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Baseline characteristics by cohort
| Measure |
Placebo
n=153 Participants
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 Participants
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 8.64 • n=99 Participants
|
66.1 Years
STANDARD_DEVIATION 8.64 • n=107 Participants
|
66.1 Years
STANDARD_DEVIATION 7.76 • n=206 Participants
|
64.8 Years
STANDARD_DEVIATION 9.26 • n=7 Participants
|
65.2 Years
STANDARD_DEVIATION 8.62 • n=31 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
189 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
413 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
118 Participants
n=7 Participants
|
512 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 4, 12, 24Population: Intent-to-treat (ITT) population consisted of all participants randomized to treatment and who received at least one dose of study drug. Only those participants with data available at the specified time points were analyzed.
Exercise tolerance was assessed using the 6MWD. If a participant was recorded as having used supplemental oxygen or a walking aid (including sitting down then continuing walking) or a technical problem during a 6MWD then that walk was considered as invalid; otherwise the 6MWD was considered as valid. The baseline 6MWD value was defined as the longest distance walked, for a valid walk, at Visit 2. Variability between the distances walked during the first six-minute walk test (6MWD1) and the second six-minute walk test (6MWD2) being compared was defined as: Variability = \[100 x (6MWD2 - 6MWD1)\]/6MWD1. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 Participants
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24
Week 4
|
314.4 Meter (m)
Standard Error 2.79
|
311.8 Meter (m)
Standard Error 2.84
|
313.2 Meter (m)
Standard Error 2.78
|
319.9 Meter (m)
Standard Error 2.83
|
|
Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24
Week 12
|
321.6 Meter (m)
Standard Error 3.53
|
322.2 Meter (m)
Standard Error 3.58
|
320.2 Meter (m)
Standard Error 3.50
|
323.4 Meter (m)
Standard Error 3.65
|
|
Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24
Week 24
|
330.6 Meter (m)
Standard Error 4.13
|
324.0 Meter (m)
Standard Error 4.19
|
325.9 Meter (m)
Standard Error 4.09
|
327.2 Meter (m)
Standard Error 4.27
|
SECONDARY outcome
Timeframe: Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24Population: ITT population. Only those participants with data available at the specified time points were analyzed.
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Pre and post-bronchodilator spirometry was performed by the investigator. For post-bronchodilator measurements, spirometry was performed 10-15 minutes after inhalation of 400/360 microgram (mcg) of salbutamol/albuterol. Participants were asked to withhold all bronchodilator therapy (regularly used ipratropium bromide and salbutamol/albuterol used as required) for at least 4 hours prior to spirometric testing. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values.Baseline visit was Visit 2 (Week 0).
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 Participants
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 4
|
2 Millilitre(mL)
Standard Error 13.6
|
1 Millilitre(mL)
Standard Error 13.9
|
-5 Millilitre(mL)
Standard Error 13.7
|
30 Millilitre(mL)
Standard Error 13.9
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 8
|
9 Millilitre(mL)
Standard Error 15.2
|
7 Millilitre(mL)
Standard Error 15.4
|
17 Millilitre(mL)
Standard Error 15.1
|
45 Millilitre(mL)
Standard Error 15.7
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 12
|
-15 Millilitre(mL)
Standard Error 15.0
|
1 Millilitre(mL)
Standard Error 15.2
|
4 Millilitre(mL)
Standard Error 15.0
|
34 Millilitre(mL)
Standard Error 15.5
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 16
|
-7 Millilitre(mL)
Standard Error 15.4
|
15 Millilitre(mL)
Standard Error 15.6
|
18 Millilitre(mL)
Standard Error 15.3
|
17 Millilitre(mL)
Standard Error 15.9
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 20
|
-13 Millilitre(mL)
Standard Error 15.5
|
-7 Millilitre(mL)
Standard Error 15.6
|
20 Millilitre(mL)
Standard Error 15.5
|
16 Millilitre(mL)
Standard Error 16.2
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 24
|
-1 Millilitre(mL)
Standard Error 15.2
|
3 Millilitre(mL)
Standard Error 15.3
|
17 Millilitre(mL)
Standard Error 15.2
|
14 Millilitre(mL)
Standard Error 15.8
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 4
|
-2 Millilitre(mL)
Standard Error 12.8
|
3 Millilitre(mL)
Standard Error 13.1
|
14 Millilitre(mL)
Standard Error 12.8
|
30 Millilitre(mL)
Standard Error 13.1
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 8
|
8 Millilitre(mL)
Standard Error 15.7
|
7 Millilitre(mL)
Standard Error 16.0
|
14 Millilitre(mL)
Standard Error 15.6
|
51 Millilitre(mL)
Standard Error 16.3
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 12
|
-1 Millilitre(mL)
Standard Error 15.8
|
-11 Millilitre(mL)
Standard Error 16.0
|
9 Millilitre(mL)
Standard Error 15.8
|
37 Millilitre(mL)
Standard Error 6.3
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 16
|
1 Millilitre(mL)
Standard Error 15.4
|
-6 Millilitre(mL)
Standard Error 15.6
|
20 Millilitre(mL)
Standard Error 15.3
|
27 Millilitre(mL)
Standard Error 15.9
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 20
|
-4 Millilitre(mL)
Standard Error 15.4
|
-22 Millilitre(mL)
Standard Error 15.6
|
23 Millilitre(mL)
Standard Error 15.4
|
10 Millilitre(mL)
Standard Error 16.1
|
|
Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 24
|
3 Millilitre(mL)
Standard Error 15.6
|
-6 Millilitre(mL)
Standard Error 15.7
|
24 Millilitre(mL)
Standard Error 15.6
|
10 Millilitre(mL)
Standard Error 16.1
|
SECONDARY outcome
Timeframe: Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24Population: ITT population. Only those participants with data available at the specified time points were analyzed.
FVC is the total amount of air exhaled during the lung function test. and post-bronchodilator spirometry was performed by the investigator. For post-bronchodilator measurements, spirometry was performed 10-15 minutes after inhalation of 400/360 microgram (mcg) of salbutamol/albuterol. Participants were asked to withhold all bronchodilator therapy (regularly used ipratropium bromide and salbutamol/albuterol used as required) for at least 4 hours prior to spirometric testing. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values.. Baseline visit was Visit 2 (Week 0).
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 Participants
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 4
|
-24 mL
Standard Error 28.3
|
-11 mL
Standard Error 28.9
|
-55 mL
Standard Error 28.3
|
33 mL
Standard Error 28.9
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 8
|
8 mL
Standard Error 29.8
|
-2 mL
Standard Error 30.4
|
-5 mL
Standard Error 29.6
|
54 mL
Standard Error 30.9
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 12
|
-50 mL
Standard Error 31.4
|
-5 mL
Standard Error 31.8
|
-34 mL
Standard Error 31.3
|
25 mL
Standard Error 32.4
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 16
|
-34 mL
Standard Error 32.3
|
-24 mL
Standard Error 32.6
|
-9 mL
Standard Error 32.0
|
8 mL
Standard Error 33.3
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 20
|
-20 mL
Standard Error 31.9
|
-51 mL
Standard Error 32.2
|
-13 mL
Standard Error 31.9
|
13 mL
Standard Error 33.4
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Pre-Bronchodilator Week 24
|
-18 mL
Standard Error 32.1
|
-41 mL
Standard Error 32.4
|
-25 mL
Standard Error 32.1
|
25 mL
Standard Error 33.4
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 4
|
-36 mL
Standard Error 25.8
|
-29 mL
Standard Error 26.3
|
-24 mL
Standard Error 25.8
|
35 mL
Standard Error 26.4
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 8
|
3 mL
Standard Error 29.2
|
-22 mL
Standard Error 29.7
|
-27 mL
Standard Error 29.0
|
69 mL
Standard Error 30.3
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 12
|
-23 mL
Standard Error 31.2
|
-34 mL
Standard Error 31.6
|
-10 mL
Standard Error 31.2
|
52 mL
Standard Error 32.2
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 16
|
-17 mL
Standard Error 31.0
|
-48 mL
Standard Error 31.4
|
-1 mL
Standard Error 30.8
|
55 mL
Standard Error 32.0
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 20
|
-14 mL
Standard Error 31.2
|
-78 mL
Standard Error 31.5
|
-26 mL
Standard Error 31.1
|
35 mL
Standard Error 32.6
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Post-Bronchodilator Week 24
|
-15 mL
Standard Error 31.2
|
-43 mL
Standard Error 31.5
|
-5 mL
Standard Error 31.2
|
20 mL
Standard Error 32.4
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12, 24Population: ITT population. Only those participants with data available at the specified time points were analyzed.
The SGRQ-C questionnaire had 14 questions of COPD and participant had to rate each question. These 14 questions were separated to evaluate the three components of SGRQ-C. These three components were symptom component (question 1 to 7), activity component (question 9 and 12) and impact component (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Change from Baseline was calculated as the specified time point value minus the Baseline value. Baseline visit was Visit 2 (Week 0).
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 Participants
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Change From Baseline in St Georges Respiratory Questionnaire for COPD (SGRQ-C) at Week 12 and 24
Week 12
|
51.1 Score on scale
Standard Error 0.98
|
50.6 Score on scale
Standard Error 0.99
|
52.6 Score on scale
Standard Error 0.98
|
49.3 Score on scale
Standard Error 1.01
|
|
Change From Baseline in St Georges Respiratory Questionnaire for COPD (SGRQ-C) at Week 12 and 24
Week 24
|
50.6 Score on scale
Standard Error 1.11
|
51.0 Score on scale
Standard Error 1.12
|
52.5 Score on scale
Standard Error 1.10
|
49.2 Score on scale
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Baseline(Week 0) and Week 12, 24Population: ITT population. Only those participants with data available at the specified time points were analyzed.
A plethysmograph is an instrument for measuring changes in volume within an organ or whole body (usually resulting from fluctuations in the amount of blood or air it contains). Plethysmography was used to assess IC, RV, TGV at FRC, SLV, and TLC. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 Participants
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
IC,Week 12
|
-26 mL
Standard Error 34.7
|
-4 mL
Standard Error 34.2
|
-80 mL
Standard Error 34.0
|
13 mL
Standard Error 35.4
|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
IC,Week 24
|
-9 mL
Standard Error 39.2
|
-53 mL
Standard Error 38.4
|
-62 mL
Standard Error 38.7
|
-50 mL
Standard Error 40.4
|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
RV, Week 12
|
-14 mL
Standard Error 69.6
|
21 mL
Standard Error 68.4
|
13 mL
Standard Error 68.1
|
-43 mL
Standard Error 70.8
|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
RV,Week 24
|
-127 mL
Standard Error 74.0
|
11 mL
Standard Error 72.6
|
72 mL
Standard Error 73.0
|
5 mL
Standard Error 76.1
|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
TLC, Week 12
|
8 mL
Standard Error 69.9
|
61 mL
Standard Error 68.8
|
25 mL
Standard Error 68.5
|
-38 mL
Standard Error 71.2
|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
TLC,Week 24
|
-112 mL
Standard Error 70.2
|
-37 mL
Standard Error 69.0
|
38 mL
Standard Error 69.3
|
-18 mL
Standard Error 72.3
|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
FRC, Week 12
|
24 mL
Standard Error 68.5
|
61 mL
Standard Error 67.5
|
92 mL
Standard Error 67.1
|
-43 mL
Standard Error 69.8
|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
FRC, Week 24
|
-109 mL
Standard Error 67.1
|
64 mL
Standard Error 65.8
|
86 mL
Standard Error 66.0
|
30 mL
Standard Error 68.9
|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
SVC, Week 12
|
50 mL
Standard Error 45.8
|
8 mL
Standard Error 45.0
|
-18 mL
Standard Error 44.8
|
25 mL
Standard Error 46.5
|
|
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
SVC,Week 24
|
27 mL
Standard Error 52.3
|
-93 mL
Standard Error 51.1
|
-10 mL
Standard Error 51.7
|
-7 mL
Standard Error 53.8
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 4, 8, 12, 24Population: ITT population. Only those participants with data available at the specified time points were analyzed.
Least square mean ratio to Baseline of plasma fibrinogen was assessed at Week 4, 8, 12, 24. Blood samples for biomarker analysis were taken at selected visits.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 Participants
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Least Square Mean Ratio to Baseline of Plasma Fibrinogen Over 24 Weeks
Week 4
|
0.97 Ratio
Standard Error 0.022
|
0.96 Ratio
Standard Error 0.022
|
0.89 Ratio
Standard Error 0.021
|
0.87 Ratio
Standard Error 0.022
|
|
Least Square Mean Ratio to Baseline of Plasma Fibrinogen Over 24 Weeks
Week 8
|
1.01 Ratio
Standard Error 0.021
|
0.95 Ratio
Standard Error 0.021
|
0.91 Ratio
Standard Error 0.020
|
0.89 Ratio
Standard Error 0.021
|
|
Least Square Mean Ratio to Baseline of Plasma Fibrinogen Over 24 Weeks
Week 12
|
0.97 Ratio
Standard Error 0.022
|
0.96 Ratio
Standard Error 0.022
|
0.89 Ratio
Standard Error 0.021
|
0.87 Ratio
Standard Error 0.022
|
|
Least Square Mean Ratio to Baseline of Plasma Fibrinogen Over 24 Weeks
Week 24
|
0.94 Ratio
Standard Error 0.021
|
0.94 Ratio
Standard Error 0.022
|
0.90 Ratio
Standard Error 0.021
|
0.89 Ratio
Standard Error 0.022
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 4, 8, 12, 24Population: ITT population. Only those participants with data available at the specified time points were analyzed.
Least square mean ratio to Baseline of HsCRP was assessed at Week 4, 8, 12, 24. Blood samples for biomarker analysis were taken at selected visits.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 Participants
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Least Square Mean Ratio to Baseline of High Sensitivity C-reactive Protein (HsCRP) Over 24 Weeks
Week 4
|
1.06 Ratio
Standard Error 0.089
|
0.93 Ratio
Standard Error 0.091
|
0.82 Ratio
Standard Error 0.089
|
0.77 Ratio
Standard Error 0.091
|
|
Least Square Mean Ratio to Baseline of High Sensitivity C-reactive Protein (HsCRP) Over 24 Weeks
Week 8
|
1.02 Ratio
Standard Error 0.086
|
1.06 Ratio
Standard Error 0.088
|
0.78 Ratio
Standard Error 0.085
|
0.75 Ratio
Standard Error 0.089
|
|
Least Square Mean Ratio to Baseline of High Sensitivity C-reactive Protein (HsCRP) Over 24 Weeks
Week 12
|
1.09 Ratio
Standard Error 0.088
|
0.99 Ratio
Standard Error 0.090
|
0.79 Ratio
Standard Error 0.088
|
0.69 Ratio
Standard Error 0.091
|
|
Least Square Mean Ratio to Baseline of High Sensitivity C-reactive Protein (HsCRP) Over 24 Weeks
Week 24
|
1.00 Ratio
Standard Error 0.088
|
0.95 Ratio
Standard Error 0.090
|
0.81 Ratio
Standard Error 0.089
|
0.86 Ratio
Standard Error 0.093
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT population.
An exacerbation of COPD is defined as a worsening of COPD symptoms requiring changes to normal treatment (other than increased use of relief salbutamol/albuterol) including antimicrobial therapy, short courses of oral steroids, other bronchodilator therapy and/or emergency treatment or hospitalization.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 Participants
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 Participants
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Total Number of Exacerbations Over 24 Weeks
|
48 Number of exacerbations
|
46 Number of exacerbations
|
47 Number of exacerbations
|
34 Number of exacerbations
|
Adverse Events
Placebo
Serious events: 17 serious events
Other events: 51 other events
Deaths: 3 deaths
Losmapimod 2.5 mg
Serious events: 12 serious events
Other events: 49 other events
Deaths: 0 deaths
Losmapimod 7.5 mg
Serious events: 14 serious events
Other events: 51 other events
Deaths: 1 deaths
Losmapimod 15 mg
Serious events: 15 serious events
Other events: 48 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=153 participants at risk
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 participants at risk
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 participants at risk
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 participants at risk
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.2%
8/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
4.0%
6/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
1.3%
2/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
2.0%
3/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Infections and infestations
Pneumonia
|
2.6%
4/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
2.7%
4/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Infections and infestations
Sinobronchitis
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
1.3%
2/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
General disorders
Chest pain
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
General disorders
Polyp
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Psychiatric disorders
Anxiety
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.66%
1/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.67%
1/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.65%
1/153 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/151 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
0.00%
0/149 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
Other adverse events
| Measure |
Placebo
n=153 participants at risk
Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 2.5 mg
n=149 participants at risk
Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 7.5 mg
n=151 participants at risk
Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
Losmapimod 15 mg
n=149 participants at risk
Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
19.6%
30/153 • Number of events 35 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
20.1%
30/149 • Number of events 41 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
23.8%
36/151 • Number of events 43 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
16.1%
24/149 • Number of events 32 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Nervous system disorders
Headache
|
8.5%
13/153 • Number of events 24 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
10.1%
15/149 • Number of events 21 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
7.3%
11/151 • Number of events 13 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
8.7%
13/149 • Number of events 19 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
12/153 • Number of events 12 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
5.4%
8/149 • Number of events 9 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
3.3%
5/151 • Number of events 6 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
6.0%
9/149 • Number of events 9 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
10/153 • Number of events 11 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
4.7%
7/149 • Number of events 7 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
3.3%
5/151 • Number of events 6 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
7.4%
11/149 • Number of events 13 • Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.
Safety population was used for the analysis of AEs.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER