Trial Outcomes & Findings for Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies. (NCT NCT00355342)
NCT ID: NCT00355342
Last Updated: 2018-07-02
Results Overview
BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
186 participants
Primary outcome timeframe
Baseline and Week 26, 52, 78, 104, 130, and 156
Results posted on
2018-07-02
Participant Flow
Total 186 participants, with chronic obstructive pulmonary disease (COPD) were randomized at 31 centers in the United States. Study duration was 14-21 day Single-Blind Run-In period, 156-week treatment period and follow-up phone contact within 2 weeks of treatment stop.
A total of 247 participants were screened for this study, of whom 61 were screen failures and 186 participants were randomized in the study.
Participant milestones
| Measure |
Salmeterol 50 mcg BID
Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline.
|
Fluticasone Propionate/Salmeterol 250/50 mcg BID
Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
92
|
|
Overall Study
COMPLETED
|
55
|
56
|
|
Overall Study
NOT COMPLETED
|
39
|
36
|
Reasons for withdrawal
| Measure |
Salmeterol 50 mcg BID
Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline.
|
Fluticasone Propionate/Salmeterol 250/50 mcg BID
Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
15
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
14
|
11
|
|
Overall Study
Sponsor terminated study
|
2
|
2
|
|
Overall Study
Overcompliant-PI discretion
|
1
|
0
|
|
Overall Study
Use of prohibited medication
|
1
|
0
|
|
Overall Study
COPD exacerbation
|
1
|
1
|
|
Overall Study
Dispensed wrong study drug kit
|
1
|
0
|
|
Overall Study
Non-compliance with Dexa scans
|
1
|
0
|
|
Overall Study
Withdrawal by participant and physician
|
1
|
0
|
|
Overall Study
Participant relocated
|
0
|
1
|
|
Overall Study
Participant discontinued study drug
|
0
|
1
|
|
Overall Study
Study management
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Use of protocol excluded medication
|
0
|
1
|
Baseline Characteristics
Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.
Baseline characteristics by cohort
| Measure |
Salmeterol 50 mcg BID
n=94 Participants
Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
Fluticasone Propionate/Salmeterol 250/50 mcg BID
n=92 Participants
Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 9.52 • n=99 Participants
|
65.4 Years
STANDARD_DEVIATION 8.36 • n=107 Participants
|
65.6 Years
STANDARD_DEVIATION 8.94 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · American Hispanic
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · South Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
92 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26, 52, 78, 104, 130, and 156Population: The Safety population - Safety population was defined as all randomized participants who are at least 50% compliant with taking study drug and have a post-Baseline BMD scan. Only those participants available at the specified time points were analyzed.
BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.
Outcome measures
| Measure |
Salmeterol 50 mcg BID
n=84 Participants
Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
Fluticasone Propionate/Salmeterol 250/50 mcg BID
n=82 Participants
Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
Week 26
|
0.5 Percent Change
Standard Error 0.33
|
0.2 Percent Change
Standard Error 0.40
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
Week 52
|
0.8 Percent Change
Standard Error 0.39
|
1.3 Percent Change
Standard Error 0.43
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
Week 78
|
1.3 Percent Change
Standard Error 0.52
|
1.0 Percent Change
Standard Error 0.64
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
Week 104
|
0.9 Percent Change
Standard Error 0.55
|
0.8 Percent Change
Standard Error 0.71
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
Week 130
|
0.3 Percent Change
Standard Error 0.66
|
1.0 Percent Change
Standard Error 0.81
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
Week 156
|
0.3 Percent Change
Standard Error 0.68
|
1.9 Percent Change
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Baseline and Week 26, 52, 78, 104, 130, and 156Population: Safety Population. Only those participants available at the specified time points were analyzed.
BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms).BMD at the total hip was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.
Outcome measures
| Measure |
Salmeterol 50 mcg BID
n=84 Participants
Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
Fluticasone Propionate/Salmeterol 250/50 mcg BID
n=82 Participants
Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
|---|---|---|
|
Percent Change From Baseline in BMD at the Total Hip
Week 26
|
-0.3 Percent Change
Standard Error 0.28
|
-0.4 Percent Change
Standard Error 0.31
|
|
Percent Change From Baseline in BMD at the Total Hip
Week 52
|
-0.5 Percent Change
Standard Error 0.32
|
-1.4 Percent Change
Standard Error 0.35
|
|
Percent Change From Baseline in BMD at the Total Hip
Week 78
|
-0.8 Percent Change
Standard Error 0.45
|
-2.1 Percent Change
Standard Error 0.46
|
|
Percent Change From Baseline in BMD at the Total Hip
Week 104
|
-1.1 Percent Change
Standard Error 0.46
|
-2.6 Percent Change
Standard Error 0.50
|
|
Percent Change From Baseline in BMD at the Total Hip
Week 130
|
-1.7 Percent Change
Standard Error 0.47
|
-2.7 Percent Change
Standard Error 0.44
|
|
Percent Change From Baseline in BMD at the Total Hip
Week 156
|
-1.8 Percent Change
Standard Error 0.57
|
-2.9 Percent Change
Standard Error 0.46
|
Adverse Events
Salmeterol 50 mcg BID
Serious events: 33 serious events
Other events: 63 other events
Deaths: 7 deaths
Fluticasone Propionate/Salmeterol 250/50 mcg BID
Serious events: 32 serious events
Other events: 72 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Salmeterol 50 mcg BID
n=94 participants at risk
Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
Fluticasone Propionate/Salmeterol 250/50 mcg BID
n=92 participants at risk
Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
11.7%
11/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
12.0%
11/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Pneumonia
|
4.3%
4/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
6.5%
6/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
General disorders
Chest pain
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
2.2%
2/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Cardiac disorders
Coronary artery disease
|
3.2%
3/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Lobar pneumonia
|
2.1%
2/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Nervous system disorders
Syncope
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
2.2%
2/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Bronchitis
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
2.2%
2/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Diverticulitis
|
2.1%
2/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.1%
2/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
2.2%
2/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
2.2%
2/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
2/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Vascular disorders
Aortic stenosis
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
General disorders
Asthenia
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Cardiac disorders
Coronary artery occlusion
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Vascular disorders
Hypertensive crisis
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
General disorders
Pain
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Renal and urinary disorders
Renal artery occlusion
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Vascular disorders
Shock
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
General disorders
Sudden cardiac death
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Investigations
Troponin increased
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
General disorders
Ulcer haemorrhage
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Injury, poisoning and procedural complications
Whiplash injury
|
1.1%
1/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
0.00%
0/92 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
Other adverse events
| Measure |
Salmeterol 50 mcg BID
n=94 participants at risk
Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
Fluticasone Propionate/Salmeterol 250/50 mcg BID
n=92 participants at risk
Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
22.3%
21/94 • Number of events 38 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
30.4%
28/92 • Number of events 48 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Sinusitis
|
16.0%
15/94 • Number of events 23 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
13.0%
12/92 • Number of events 22 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.7%
11/94 • Number of events 13 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
10.9%
10/92 • Number of events 12 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.7%
11/94 • Number of events 15 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
8.7%
8/92 • Number of events 9 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.4%
6/94 • Number of events 7 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
10.9%
10/92 • Number of events 14 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Bronchitis
|
7.4%
7/94 • Number of events 7 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
8.7%
8/92 • Number of events 11 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
9/94 • Number of events 11 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 5 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
7/94 • Number of events 7 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
7.6%
7/92 • Number of events 10 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Nervous system disorders
Headache
|
6.4%
6/94 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
8.7%
8/92 • Number of events 11 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Vascular disorders
Hypertension
|
6.4%
6/94 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
6.5%
6/92 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.4%
6/94 • Number of events 7 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
7/94 • Number of events 8 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
4.3%
4/92 • Number of events 5 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Influenza
|
4.3%
4/94 • Number of events 4 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
6.5%
6/92 • Number of events 7 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Psychiatric disorders
Anxiety
|
4.3%
4/94 • Number of events 4 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 5 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
4/94 • Number of events 4 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.1%
2/94 • Number of events 2 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
7.6%
7/92 • Number of events 11 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.4%
6/94 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
3.3%
3/92 • Number of events 3 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Oral candidiasis
|
4.3%
4/94 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 11 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.3%
4/94 • Number of events 4 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 7 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Candidiasis
|
1.1%
1/94 • Number of events 1 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
7.6%
7/92 • Number of events 12 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
General disorders
Fatigue
|
3.2%
3/94 • Number of events 3 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 5 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
3/94 • Number of events 3 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 5 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
5/94 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
3.3%
3/92 • Number of events 3 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Psychiatric disorders
Insomnia
|
2.1%
2/94 • Number of events 2 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 5 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/94 • Number of events 1 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
6.5%
6/92 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
General disorders
Oedema peripheral
|
6.4%
6/94 • Number of events 9 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Number of events 1 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/94 • Number of events 2 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 5 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.1%
1/94 • Number of events 1 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 7 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
6.5%
6/92 • Number of events 7 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
General disorders
Pain
|
5.3%
5/94 • Number of events 5 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
1.1%
1/92 • Number of events 1 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/94 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
5.4%
5/92 • Number of events 6 • Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
|
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