Trial Outcomes & Findings for Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients. (NCT NCT01120093)
NCT ID: NCT01120093
Last Updated: 2017-01-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Day 7
Results posted on
2017-01-09
Participant Flow
This study was conducted at a total of 11 centres; 10 in Germany and 1 in Belgium. The first patient was screened in Apr 2010 and the last patient visit was in Aug 2010.
Patients fulfilling inclusion/exclusion criteria at the time of the Screening Visit were entered into a run-in period of 14 ± 3 days to assess patient's disease stability.
Participant milestones
| Measure |
Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
|
Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
|
Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
|
Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
|
Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
|
|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
18
|
14
|
17
|
14
|
16
|
|
Treatment Period 1
COMPLETED
|
18
|
13
|
16
|
14
|
15
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
1
|
1
|
0
|
1
|
|
Treatment Period 2
STARTED
|
18
|
13
|
16
|
14
|
15
|
|
Treatment Period 2
COMPLETED
|
18
|
13
|
16
|
13
|
14
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
|
Treatment Period 3
STARTED
|
18
|
13
|
16
|
13
|
14
|
|
Treatment Period 3
COMPLETED
|
18
|
13
|
15
|
12
|
13
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
1
|
1
|
1
|
|
Treatment Period 4
STARTED
|
18
|
13
|
15
|
12
|
13
|
|
Treatment Period 4
COMPLETED
|
17
|
13
|
15
|
12
|
13
|
|
Treatment Period 4
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 5
STARTED
|
17
|
13
|
15
|
12
|
13
|
|
Treatment Period 5
COMPLETED
|
17
|
12
|
15
|
11
|
13
|
|
Treatment Period 5
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
|
Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
|
Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
|
Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
|
Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400
The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
|
|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 3
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 3
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 3
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 4
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 5
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=79 Participants
All patients randomized into the crossover study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Gender
Female
|
20 Participants
n=5 Participants
|
|
Gender
Male
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidinium Bromide 100 μg Bid
n=73 Participants
Aclidinium bromide 100 μg twice-daily via inhalation
|
Aclidinium Bromide 200 μg Bid
n=71 Participants
Aclidinium bromide 200 μg twice-daily via inhalation
|
Aclidinium Bromide 400 μg Bid
n=73 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Formoterol 12 μg Bid
n=74 Participants
Formoterol 12 μg twice-daily via inhalation
|
Placebo
n=73 Participants
Placebo via inhalation
|
|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment
|
0.128 Liters
Standard Error 0.022
|
0.151 Liters
Standard Error 0.022
|
0.183 Liters
Standard Error 0.022
|
0.184 Liters
Standard Error 0.022
|
-0.026 Liters
Standard Error 0.022
|
SECONDARY outcome
Timeframe: Day 7Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidinium Bromide 100 μg Bid
n=72 Participants
Aclidinium bromide 100 μg twice-daily via inhalation
|
Aclidinium Bromide 200 μg Bid
n=69 Participants
Aclidinium bromide 200 μg twice-daily via inhalation
|
Aclidinium Bromide 400 μg Bid
n=71 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Formoterol 12 μg Bid
n=72 Participants
Formoterol 12 μg twice-daily via inhalation
|
Placebo
n=72 Participants
Placebo via inhalation
|
|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment
|
0.044 Liters
Standard Error 0.021
|
0.047 Liters
Standard Error 0.021
|
0.086 Liters
Standard Error 0.021
|
0.141 Liters
Standard Error 0.021
|
-0.103 Liters
Standard Error 0.021
|
SECONDARY outcome
Timeframe: Day 7Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidinium Bromide 100 μg Bid
n=72 Participants
Aclidinium bromide 100 μg twice-daily via inhalation
|
Aclidinium Bromide 200 μg Bid
n=69 Participants
Aclidinium bromide 200 μg twice-daily via inhalation
|
Aclidinium Bromide 400 μg Bid
n=71 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Formoterol 12 μg Bid
n=74 Participants
Formoterol 12 μg twice-daily via inhalation
|
Placebo
n=72 Participants
Placebo via inhalation
|
|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment
|
0.088 Liters
Standard Error 0.021
|
0.100 Liters
Standard Error 0.021
|
0.133 Liters
Standard Error 0.021
|
0.163 Liters
Standard Error 0.021
|
-0.062 Liters
Standard Error 0.021
|
SECONDARY outcome
Timeframe: Day 7Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidinium Bromide 100 μg Bid
n=73 Participants
Aclidinium bromide 100 μg twice-daily via inhalation
|
Aclidinium Bromide 200 μg Bid
n=72 Participants
Aclidinium bromide 200 μg twice-daily via inhalation
|
Aclidinium Bromide 400 μg Bid
n=73 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Formoterol 12 μg Bid
n=74 Participants
Formoterol 12 μg twice-daily via inhalation
|
Placebo
n=75 Participants
Placebo via inhalation
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment
|
0.081 Liters
Standard Error 0.023
|
0.089 Liters
Standard Error 0.023
|
0.130 Liters
Standard Error 0.023
|
0.123 Liters
Standard Error 0.023
|
-0.025 Liters
Standard Error 0.023
|
Adverse Events
Aclidinium Bromide 100 μg Bid
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Aclidinium Bromide 200 μg Bid
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Aclidinium Bromide 400 μg Bid
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Formoterol 12 μg Bid
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aclidinium Bromide 100 μg Bid
n=73 participants at risk
Aclidinium bromide 100 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
|
Aclidinium Bromide 200 μg Bid
n=73 participants at risk
Aclidinium bromide 200 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
|
Aclidinium Bromide 400 μg Bid
n=74 participants at risk
Aclidinium bromide 400 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
|
Formoterol 12 μg Bid
n=74 participants at risk
Formoterol 12 μg twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days.
|
Placebo
n=76 participants at risk
Inhaled placebo dose for 7 days.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/74
|
0.00%
0/74
|
1.3%
1/76 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/74
|
0.00%
0/74
|
1.3%
1/76 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/74
|
0.00%
0/74
|
0.00%
0/76
|
|
Infections and infestations
Infectious exacerbation of chronic obstructive pulmonary disease
|
0.00%
0/73
|
0.00%
0/73
|
1.4%
1/74 • Number of events 1
|
0.00%
0/74
|
0.00%
0/76
|
Other adverse events
| Measure |
Aclidinium Bromide 100 μg Bid
n=73 participants at risk
Aclidinium bromide 100 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
|
Aclidinium Bromide 200 μg Bid
n=73 participants at risk
Aclidinium bromide 200 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
|
Aclidinium Bromide 400 μg Bid
n=74 participants at risk
Aclidinium bromide 400 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
|
Formoterol 12 μg Bid
n=74 participants at risk
Formoterol 12 μg twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days.
|
Placebo
n=76 participants at risk
Inhaled placebo dose for 7 days.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.5%
4/73
|
5.5%
4/73
|
6.8%
5/74
|
2.7%
2/74
|
1.3%
1/76
|
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