Trial Outcomes & Findings for Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01471171)
NCT ID: NCT01471171
Last Updated: 2017-01-04
Results Overview
Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.
COMPLETED
PHASE3
112 participants
Week 3
2017-01-04
Participant Flow
This study was conducted at 16 enrolling sites. A total of 14 sites randomised patients: 10 sites in Germany, 3 sites in Spain and one site in the United Kingdom. The first patient was screened in November 2011 and the last patient visit was in June 2012.
Eligible patients entered a 14-21 day run-in period to assess disease stability. During this period, one site visit was performed to familiarise patients with study testing procedures (body plethysmography, spirometry and a constant work rate cycle exercise test).
Participant milestones
| Measure |
Aclidinium Bromide 400 μg - Placebo
The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
|
Placebo - Aclidinium Bromide 400 μg
The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
57
|
55
|
|
Treatment Period 1
COMPLETED
|
53
|
54
|
|
Treatment Period 1
NOT COMPLETED
|
4
|
1
|
|
Treatment Period 2
STARTED
|
53
|
54
|
|
Treatment Period 2
COMPLETED
|
52
|
54
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Aclidinium Bromide 400 μg - Placebo
The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
|
Placebo - Aclidinium Bromide 400 μg
The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
|
|---|---|---|
|
Treatment Period 1
Adverse Event
|
4
|
1
|
|
Treatment Period 2
Adverse Event
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Overall Study Safety Population
n=112 Participants
All patients randomized into the crossover study were included in the safety population
|
|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Gender
Female
|
36 Participants
n=5 Participants
|
|
Gender
Male
|
76 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
89 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 3Population: Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.
Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.
Outcome measures
| Measure |
Aclidinium Bromide 400 μg Bid
n=109 Participants
Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
|
Placebo
n=107 Participants
Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
|
|---|---|---|
|
Change From Baseline in Endurance Time (Seconds)
|
68.3 Seconds
Standard Error 18.8
|
9.8 Seconds
Standard Error 19.0
|
SECONDARY outcome
Timeframe: Week 3Population: Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.
Change from baseline in trough IC after 3 weeks of treatment
Outcome measures
| Measure |
Aclidinium Bromide 400 μg Bid
n=107 Participants
Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
|
Placebo
n=104 Participants
Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
|
|---|---|---|
|
Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)
|
0.098 Litres
Standard Error 0.024
|
0.020 Litres
Standard Error 0.025
|
SECONDARY outcome
Timeframe: Week 3Population: Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.
Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.
Outcome measures
| Measure |
Aclidinium Bromide 400 μg Bid
n=109 Participants
Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
|
Placebo
n=107 Participants
Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
|
|---|---|---|
|
Change From Baseline in Intensity of Dyspnoea
|
-0.48 Units on a scale
Standard Error 0.20
|
0.15 Units on a scale
Standard Error 0.20
|
Adverse Events
Aclidinium Bromide 400 μg Bid
Placebo
Serious adverse events
| Measure |
Aclidinium Bromide 400 μg Bid
n=111 participants at risk
Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
|
Placebo
n=108 participants at risk
Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
|
|---|---|---|
|
Investigations
Troponin T increased
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
Other adverse events
| Measure |
Aclidinium Bromide 400 μg Bid
n=111 participants at risk
Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
|
Placebo
n=108 participants at risk
Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.3%
7/111
|
3.7%
4/108
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All the information related to this clinical trial is considered strictly confidential and is the property of Almirall. This information will not be given to a third party without the written consent of Almirall. Publication and/or presentation, whether complete or partial, of any part of the data or results of this trial will be subject to revision and written agreement between the investigator and Almirall.
- Publication restrictions are in place
Restriction type: OTHER