Trial Outcomes & Findings for Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (NCT NCT00510510)
NCT ID: NCT00510510
Last Updated: 2012-05-21
Results Overview
The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
281 participants
Primary outcome timeframe
28 days
Results posted on
2012-05-21
Participant Flow
Participant milestones
| Measure |
NVA237 100 µg
NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
NVA237 200 µg
NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
Placebo
Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
98
|
91
|
|
Overall Study
COMPLETED
|
87
|
89
|
74
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
17
|
Reasons for withdrawal
| Measure |
NVA237 100 µg
NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
NVA237 200 µg
NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
Placebo
Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
6
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
|
Overall Study
Subjects no longer requires study drug
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
4
|
Baseline Characteristics
Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
NVA237 100 µg
n=92 Participants
NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
|
NVA237 200 µg
n=98 Participants
NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
Placebo
n=91 Participants
Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
64.2 years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 9.04 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 8.82 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.
Outcome measures
| Measure |
NVA237 100 µg
n=92 Participants
NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
|
NVA237 200 µg
n=98 Participants
NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
Placebo
n=91 Participants
Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
|---|---|---|---|
|
Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Total number of patients with any AE
|
26 Participants
|
26 Participants
|
24 Participants
|
|
Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Total number with any significant AE
|
3 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 28 DaysForced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 \& 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.
Outcome measures
| Measure |
NVA237 100 µg
n=92 Participants
NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
|
NVA237 200 µg
n=98 Participants
NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
Placebo
n=91 Participants
Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
|---|---|---|---|
|
Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day
Trough FEV1 Day 1
|
1.465 Liters
Standard Error 0.0152
|
1.480 Liters
Standard Error 0.0149
|
1.334 Liters
Standard Error 0.0154
|
|
Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day
Trough FEV1 Day 28
|
1.502 Liters
Standard Error 0.0182
|
1.492 Liters
Standard Error 0.0180
|
1.341 Liters
Standard Error 0.0200
|
Adverse Events
NVA237 100 µg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
NVA237 200 µg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NVA237 100 µg
n=92 participants at risk
NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
|
NVA237 200 µg
n=98 participants at risk
NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
Placebo
n=91 participants at risk
Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/92
|
1.0%
1/98
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/92
|
0.00%
0/98
|
1.1%
1/91
|
Other adverse events
| Measure |
NVA237 100 µg
n=92 participants at risk
NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
|
NVA237 200 µg
n=98 participants at risk
NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
Placebo
n=91 participants at risk
Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
3/92
|
7.1%
7/98
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.4%
5/92
|
3.1%
3/98
|
4.4%
4/91
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER