Trial Outcomes & Findings for A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00500318)
NCT ID: NCT00500318
Last Updated: 2017-01-06
Results Overview
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
COMPLETED
PHASE3
181 participants
From baseline Week 0 (Visit 4) to Week 6 (Visit 6)
2017-01-06
Participant Flow
Patient recruitment occurred from July to October of 2007 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
All demographic and baseline characteristics were analyzed descriptively just for the Safety population.
Participant milestones
| Measure |
Aclidinium
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
Dose-matched placebo, oral inhalation, once per day.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
95
|
|
Overall Study
COMPLETED
|
81
|
78
|
|
Overall Study
NOT COMPLETED
|
5
|
17
|
Reasons for withdrawal
| Measure |
Aclidinium
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
Dose-matched placebo, oral inhalation, once per day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
8
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Other Reason
|
0
|
1
|
Baseline Characteristics
A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Aclidinium
n=86 Participants
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
n=95 Participants
Dose-matched placebo, oral inhalation, once per day.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Gender
Female
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Gender
Male
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
75 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline Week 0 (Visit 4) to Week 6 (Visit 6)Population: Missing data for patients who withdrew due to COPD exacerbations was imputed using the Worst Observation Carried Forward (WOCF) of all Endurance time (ET), while ETs that were missing for other reasons were imputed using the Last Observation Carried Forward (LOCF) method based on the last visit available.
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
Outcome measures
| Measure |
Aclidinium
n=86 Participants
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
n=94 Participants
Dose-matched placebo, oral inhalation, once per day.
|
|---|---|---|
|
Change From Baseline in Exercise Endurance Time (ET)
|
129.45 Seconds
Standard Error 31.19
|
13.01 Seconds
Standard Error 30.97
|
SECONDARY outcome
Timeframe: Change from baseline (Visit 4) at Week 6 (Visit 6)Population: The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).
Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).
Outcome measures
| Measure |
Aclidinium
n=86 Participants
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
n=92 Participants
Dose-matched placebo, oral inhalation, once per day.
|
|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1)
|
0.090 L
Standard Error 0.018
|
-0.010 L
Standard Error 0.018
|
SECONDARY outcome
Timeframe: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)Population: The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).
Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).
Outcome measures
| Measure |
Aclidinium
n=83 Participants
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
n=90 Participants
Dose-matched placebo, oral inhalation, once per day.
|
|---|---|---|
|
Trough Inspiratory Capacity (IC)
|
0.083 L
Standard Error 0.032
|
-0.019 L
Standard Error 0.032
|
SECONDARY outcome
Timeframe: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)Population: The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).
Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).
Outcome measures
| Measure |
Aclidinium
n=81 Participants
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
n=78 Participants
Dose-matched placebo, oral inhalation, once per day.
|
|---|---|---|
|
Functional Residual Capacity (FRC)
|
-0.138 L
Standard Error 0.061
|
-0.076 L
Standard Error 0.064
|
SECONDARY outcome
Timeframe: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)Population: The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).
Ratio of trough Inspiratory Capacity verses Total Lung Capacity.
Outcome measures
| Measure |
Aclidinium
n=78 Participants
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
n=75 Participants
Dose-matched placebo, oral inhalation, once per day.
|
|---|---|---|
|
Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio
|
0.014 ratio
Standard Error 0.006
|
-0.003 ratio
Standard Error 0.006
|
Adverse Events
Aclidinium
Placebo
Serious adverse events
| Measure |
Aclidinium
n=86 participants at risk
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
n=95 participants at risk
Dose-matched placebo, oral inhalation, once per day.
|
|---|---|---|
|
Gastrointestinal disorders
Ileitis
|
1.2%
1/86 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
0.00%
0/95 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
|
Gastrointestinal disorders
Diverticulum
|
1.2%
1/86 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
0.00%
0/95 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/86 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
1.1%
1/95 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/86 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
1.1%
1/95 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/86 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
1.1%
1/95 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
Other adverse events
| Measure |
Aclidinium
n=86 participants at risk
Aclidinium bromide, 200 micrograms, oral inhalation once per day.
|
Placebo
n=95 participants at risk
Dose-matched placebo, oral inhalation, once per day.
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.8%
5/86 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
7.4%
7/95 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disorder
|
2.3%
2/86 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
7.4%
7/95 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
5/86 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
3.2%
3/95 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.8%
5/86 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
2.1%
2/95 • Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study will be the property of the Sponsor. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER