Trial Outcomes & Findings for A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD (NCT NCT02276222)
NCT ID: NCT02276222
Last Updated: 2018-03-13
Results Overview
A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1087 participants
Primary outcome timeframe
Up to Week 48
Results posted on
2018-03-13
Participant Flow
Participant milestones
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Overall Study
STARTED
|
621
|
466
|
|
Overall Study
COMPLETED
|
436
|
402
|
|
Overall Study
NOT COMPLETED
|
185
|
64
|
Reasons for withdrawal
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Overall Study
Adverse Event
|
62
|
11
|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
13
|
3
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
79
|
33
|
|
Overall Study
non compliance with study medication
|
6
|
2
|
|
Overall Study
sponsor decision
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
15
|
5
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
sheduling conflict
|
1
|
0
|
|
Overall Study
subject withdrew after randomization
|
1
|
0
|
Baseline Characteristics
A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD
Baseline characteristics by cohort
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
Total
n=1086 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
330 Participants
n=99 Participants
|
256 Participants
n=107 Participants
|
586 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
290 Participants
n=99 Participants
|
210 Participants
n=107 Participants
|
500 Participants
n=206 Participants
|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 8.46 • n=99 Participants
|
63.3 years
STANDARD_DEVIATION 8.97 • n=107 Participants
|
63.3 years
STANDARD_DEVIATION 8.68 • n=206 Participants
|
|
Sex: Female, Male
Female
|
270 Participants
n=99 Participants
|
206 Participants
n=107 Participants
|
476 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
350 Participants
n=99 Participants
|
260 Participants
n=107 Participants
|
610 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
611 Participants
n=99 Participants
|
457 Participants
n=107 Participants
|
1068 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
582 Participants
n=99 Participants
|
436 Participants
n=107 Participants
|
1018 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
25 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
34 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
556 Participants
n=99 Participants
|
421 Participants
n=107 Participants
|
977 Participants
n=206 Participants
|
|
cardiovascular risk (low/high) and categories for high cardiovascular risk
low cardiovascular risk
|
219 Participants
n=99 Participants
|
169 Participants
n=107 Participants
|
388 Participants
n=206 Participants
|
|
cardiovascular risk (low/high) and categories for high cardiovascular risk
high cardiovascular risk
|
401 Participants
n=99 Participants
|
297 Participants
n=107 Participants
|
698 Participants
n=206 Participants
|
|
cardiovascular risk (low/high) and categories for high cardiovascular risk
ischemic heart disease
|
61 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
cardiovascular risk (low/high) and categories for high cardiovascular risk
cerebrovascular disease
|
28 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
cardiovascular risk (low/high) and categories for high cardiovascular risk
periheral arterial disease
|
39 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
cardiovascular risk (low/high) and categories for high cardiovascular risk
clinically significant arrhythmia
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
cardiovascular risk (low/high) and categories for high cardiovascular risk
heart failure
|
23 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
cardiovascular risk (low/high) and categories for high cardiovascular risk
hyertension
|
362 Participants
n=99 Participants
|
275 Participants
n=107 Participants
|
637 Participants
n=206 Participants
|
|
background long-acting beta (2) agonist (LABA) use
background LABA use -yes
|
267 Participants
n=99 Participants
|
192 Participants
n=107 Participants
|
459 Participants
n=206 Participants
|
|
background long-acting beta (2) agonist (LABA) use
background LABA use -no
|
353 Participants
n=99 Participants
|
274 Participants
n=107 Participants
|
627 Participants
n=206 Participants
|
|
Forced expiratory volume in one second (FEV1)
|
1.3399 liters
STANDARD_DEVIATION 0.49604 • n=99 Participants
|
1.3257 liters
STANDARD_DEVIATION 0.50186 • n=107 Participants
|
1.3365 liters
STANDARD_DEVIATION 0.51414 • n=206 Participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAE)
|
430 participants
|
312 participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Percentage of Subjects With Treatment-emergent Adverse Events
|
69.4 percentage of participants
|
67.0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Number of Subjects With Treatment-emergent Serious Adverse Events (SAE)
|
76 participants
|
49 participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Percentage of Subjects With Treatment-emergent Serious Adverse
|
12.3 percentage of participants
|
10.5 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Number of Subjects Who Discontinue the Study Due to TEAE
|
62 participants
|
13 participants
|
PRIMARY outcome
Timeframe: Up to 48 WeeksPopulation: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Percentage of Subjects Who Discontinue the Study Due to TEAE
|
10.0 percentage of participants
|
2.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
non-fatal stroke
|
0 participants
|
1 participants
|
|
Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
MACE score
|
3 participants
|
8 participants
|
|
Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
cardiovascular death
|
1 participants
|
2 participants
|
|
Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
non-fatal myocardial infarction
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 48 WeeksPopulation: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
non-fatal myocardial infarction
|
0.3 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
MACE score
|
0.5 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
cardiovascular death
|
0.2 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
non-fatal stroke
|
0 percentage of participants
|
0.2 percentage of participants
|
SECONDARY outcome
Timeframe: up to week 48Population: Incidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.
All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
MACE score
|
6.4 event per 1000 person years
|
20.3 event per 1000 person years
|
|
Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
cardiovascular death
|
2.1 event per 1000 person years
|
5.1 event per 1000 person years
|
|
Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
non-fatal myocardial infarction
|
4.3 event per 1000 person years
|
12.7 event per 1000 person years
|
|
Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
non-fatal stroke
|
0 event per 1000 person years
|
2.5 event per 1000 person years
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the FEV1 values collected at the end of the dosing interval at each clinic visit. The mean change from baseline in trough FEV1 over the 48 week treatment period is calculated by averaging the trough FEV1 changes from baseline across all study visits while subjects are taking randomized treatment. Values affected by other medication use were to be set to missing.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 Participants
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 Participants
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects
|
0.1016 liters
Standard Error 0.00698
|
0.0931 liters
Standard Error 0.00779
|
Adverse Events
SUN-101 50 mcg BID eFlow (CS) Nebulizer
Serious events: 76 serious events
Other events: 195 other events
Deaths: 3 deaths
Spiriva 18 mcg QD Handihaler
Serious events: 49 serious events
Other events: 133 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 participants at risk
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 participants at risk
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Cardiac disorders
acute myocardial infarction
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Cardiac disorders
angina pectoris
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Cardiac disorders
atrial fibrillation
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Cardiac disorders
arterial flutter
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Cardiac disorders
cardiac failure congestive
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.43%
2/466 • Number of events 2 • up to week 48
|
|
Cardiac disorders
cardio respiratory arrest
|
0.48%
3/620 • Number of events 3 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Cardiac disorders
coronary artery disease
|
0.48%
3/620 • Number of events 3 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Cardiac disorders
myocardial infraction
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Cardiac disorders
verntricular arrhythmia
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Eye disorders
diplopia
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Gastrointestinal disorders
abdominal pain
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Gastrointestinal disorders
colitis
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Gastrointestinal disorders
constipation
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Gastrointestinal disorders
duodenal ulcer, obstructive
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Gastrointestinal disorders
gastric ulcer haemorrhage
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Gastrointestinal disorders
gastric ulcer perforation
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Gastrointestinal disorders
gastrointestinal perforation
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Gastrointestinal disorders
haematochezia
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Gastrointestinal disorders
large intestinal obstruction
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Gastrointestinal disorders
pancreatitis
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Gastrointestinal disorders
rectal haemorrhage
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
General disorders
chest pain
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
General disorders
generalized oedema
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
General disorders
non-cardiac chest pain
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.43%
2/466 • Number of events 2 • up to week 48
|
|
General disorders
pain
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
General disorders
pyrexia
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Hepatobiliary disorders
cholecystitis
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Hepatobiliary disorders
choleithiasis
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Infections and infestations
abdominal infection
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Infections and infestations
appendicitis
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Infections and infestations
bronchitis
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Infections and infestations
gastroenteritis
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Infections and infestations
gastronenteritis viral
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Infections and infestations
osteomyelitis
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Infections and infestations
pheumonia
|
1.3%
8/620 • Number of events 8 • up to week 48
|
0.64%
3/466 • Number of events 3 • up to week 48
|
|
Infections and infestations
sepsis
|
0.00%
0/620 • up to week 48
|
0.64%
3/466 • Number of events 3 • up to week 48
|
|
Infections and infestations
septic shock
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Infections and infestations
systemic candida
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Infections and infestations
urinary tract infection
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.21%
1/466 • Number of events 3 • up to week 48
|
|
Infections and infestations
urosepsis
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Injury, poisoning and procedural complications
accidental overdose
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.48%
3/620 • Number of events 3 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Injury, poisoning and procedural complications
impacted fracture
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Injury, poisoning and procedural complications
joint injury
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Injury, poisoning and procedural complications
pubis fracture
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Injury, poisoning and procedural complications
road traffic accident
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Injury, poisoning and procedural complications
subdural haematoma
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Injury, poisoning and procedural complications
vascular pseudoaneurysm
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Metabolism and nutrition disorders
dehydration
|
0.16%
1/620 • Number of events 2 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Metabolism and nutrition disorders
hypokalaemia
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Metabolism and nutrition disorders
malnutrition
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Musculoskeletal and connective tissue disorders
joint effsion
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.43%
2/466 • Number of events 3 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
benign lung neoplasm
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bladder cancer
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
carcinoid tumor of the apendix
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colon cancer
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
endometrial cancer
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung adenocarcinoma
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meningioma
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastatic renal cell carcinoma
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
non-hodgkins lymphoma
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pancreatic crcinoma
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
rectal cancer
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
small cell lung cancer stage unspecified
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Nervous system disorders
hashimoto's encephalopathy
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Nervous system disorders
lumbar radiculopathy
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Nervous system disorders
multile sclerosis relapse
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Nervous system disorders
serotonin syndrome
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Nervous system disorders
syncope
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Nervous system disorders
transient ischaemic attack
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Psychiatric disorders
anxiety
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Nervous system disorders
suicidal ideation
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Renal and urinary disorders
renal failure
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Renal and urinary disorders
renal mass
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
2.7%
17/620 • Number of events 18 • up to week 48
|
3.0%
14/466 • Number of events 15 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
pleurisy
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia aspiration
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.48%
3/620 • Number of events 3 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.43%
2/466 • Number of events 2 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Skin and subcutaneous tissue disorders
angioedema
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Vascular disorders
aortic aneurysm
|
0.32%
2/620 • Number of events 2 • up to week 48
|
0.21%
1/466 • Number of events 2 • up to week 48
|
|
Vascular disorders
arterios clerosis
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
|
Vascular disorders
hypertension
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
pluritic pain
|
0.16%
1/620 • Number of events 1 • up to week 48
|
0.00%
0/466 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/620 • up to week 48
|
0.21%
1/466 • Number of events 1 • up to week 48
|
Other adverse events
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=620 participants at risk
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
|
Spiriva 18 mcg QD Handihaler
n=466 participants at risk
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
|
|---|---|---|
|
Infections and infestations
nasopharyngitis
|
4.0%
25/620 • Number of events 31 • up to week 48
|
6.0%
28/466 • Number of events 32 • up to week 48
|
|
Infections and infestations
upper respiratory tract infection
|
6.1%
38/620 • Number of events 42 • up to week 48
|
5.4%
25/466 • Number of events 28 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
14.7%
91/620 • Number of events 119 • up to week 48
|
17.6%
82/466 • Number of events 107 • up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
11.8%
73/620 • Number of events 78 • up to week 48
|
5.6%
26/466 • Number of events 28 • up to week 48
|
Additional Information
Respiratory Medical Director
Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study , the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER