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Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

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ClinicalTrials.gov Identifier: NCT01120093
Recruitment Status : Completed
First Posted : May 10, 2010
Results First Posted : September 12, 2012
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: Aclidinium bromide 100 μg bid
Drug: Aclidinium bromide 200 μg bid
Drug: Aclidininum bromide 400 μg bid
Drug: Placebo
Drug: Formoterol 12 μg bid
Enrollment 79
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100 Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200 Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400
Hide Arm/Group Description

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.

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.

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.

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.

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.

Period Title: Treatment Period 1
Started 18 14 17 14 16
Completed 18 13 16 14 15
Not Completed 0 1 1 0 1
Reason Not Completed
Adverse Event             0             0             1             0             1
Withdrawal by Subject             0             1             0             0             0
Period Title: Treatment Period 2
Started 18 13 16 14 15
Completed 18 13 16 13 14
Not Completed 0 0 0 1 1
Reason Not Completed
Adverse Event             0             0             0             1             0
Withdrawal by Subject             0             0             0             0             1
Period Title: Treatment Period 3
Started 18 13 16 13 14
Completed 18 13 15 12 13
Not Completed 0 0 1 1 1
Reason Not Completed
Lack of Efficacy             0             0             0             1             0
Adverse Event             0             0             0             0             1
Withdrawal by Subject             0             0             1             0             0
Period Title: Treatment Period 4
Started 18 13 15 12 13
Completed 17 13 15 12 13
Not Completed 1 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0
Period Title: Treatment Period 5
Started 17 13 15 12 13
Completed 17 12 15 11 13
Not Completed 0 1 0 1 0
Reason Not Completed
Adverse Event             0             1             0             1             0
Arm/Group Title Overall Study Population
Hide Arm/Group Description All patients randomized into the crossover study
Overall Number of Baseline Participants 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
<=18 years
0
   0.0%
Between 18 and 65 years
47
  59.5%
>=65 years
32
  40.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants
61.1  (8.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Female
20
  25.3%
Male
59
  74.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants
Belgium 3
Germany 76
1.Primary Outcome
Title Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment
Hide Description [Not Specified]
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aclidinium Bromide 100 μg Bid Aclidinium Bromide 200 μg Bid Aclidinium Bromide 400 μg Bid Formoterol 12 μg Bid Placebo
Hide Arm/Group Description:
Aclidinium bromide 100 μg twice-daily via inhalation
Aclidinium bromide 200 μg twice-daily via inhalation
Aclidinium bromide 400 μg twice-daily via inhalation
Formoterol 12 μg twice-daily via inhalation
Placebo via inhalation
Overall Number of Participants Analyzed 73 71 73 74 73
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.128  (0.022) 0.151  (0.022) 0.183  (0.022) 0.184  (0.022) -0.026  (0.022)
2.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment
Hide Description [Not Specified]
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aclidinium Bromide 100 μg Bid Aclidinium Bromide 200 μg Bid Aclidinium Bromide 400 μg Bid Formoterol 12 μg Bid Placebo
Hide Arm/Group Description:
Aclidinium bromide 100 μg twice-daily via inhalation
Aclidinium bromide 200 μg twice-daily via inhalation
Aclidinium bromide 400 μg twice-daily via inhalation
Formoterol 12 μg twice-daily via inhalation
Placebo via inhalation
Overall Number of Participants Analyzed 72 69 71 72 72
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.044  (0.021) 0.047  (0.021) 0.086  (0.021) 0.141  (0.021) -0.103  (0.021)
3.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment
Hide Description [Not Specified]
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aclidinium Bromide 100 μg Bid Aclidinium Bromide 200 μg Bid Aclidinium Bromide 400 μg Bid Formoterol 12 μg Bid Placebo
Hide Arm/Group Description:
Aclidinium bromide 100 μg twice-daily via inhalation
Aclidinium bromide 200 μg twice-daily via inhalation
Aclidinium bromide 400 μg twice-daily via inhalation
Formoterol 12 μg twice-daily via inhalation
Placebo via inhalation
Overall Number of Participants Analyzed 72 69 71 74 72
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.088  (0.021) 0.100  (0.021) 0.133  (0.021) 0.163  (0.021) -0.062  (0.021)
4.Secondary Outcome
Title Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment
Hide Description [Not Specified]
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aclidinium Bromide 100 μg Bid Aclidinium Bromide 200 μg Bid Aclidinium Bromide 400 μg Bid Formoterol 12 μg Bid Placebo
Hide Arm/Group Description:
Aclidinium bromide 100 μg twice-daily via inhalation
Aclidinium bromide 200 μg twice-daily via inhalation
Aclidinium bromide 400 μg twice-daily via inhalation
Formoterol 12 μg twice-daily via inhalation
Placebo via inhalation
Overall Number of Participants Analyzed 73 72 73 74 75
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.081  (0.023) 0.089  (0.023) 0.130  (0.023) 0.123  (0.023) -0.025  (0.023)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aclidinium Bromide 100 μg Bid Aclidinium Bromide 200 μg Bid Aclidinium Bromide 400 μg Bid Formoterol 12 μg Bid Placebo
Hide Arm/Group Description 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 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 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 twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days. Inhaled placebo dose for 7 days.
All-Cause Mortality
Aclidinium Bromide 100 μg Bid Aclidinium Bromide 200 μg Bid Aclidinium Bromide 400 μg Bid Formoterol 12 μg Bid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aclidinium Bromide 100 μg Bid Aclidinium Bromide 200 μg Bid Aclidinium Bromide 400 μg Bid Formoterol 12 μg Bid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/73 (0.00%)      1/73 (1.37%)      1/74 (1.35%)      0/74 (0.00%)      2/76 (2.63%)    
Cardiac disorders           
Myocardial infarction  1  0/73 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0
Infections and infestations           
Infectious exacerbation of chronic obstructive pulmonary disease  1  0/73 (0.00%)  0 0/73 (0.00%)  0 1/74 (1.35%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0
Injury, poisoning and procedural complications           
Thermal burn  1  0/73 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  0/73 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aclidinium Bromide 100 μg Bid Aclidinium Bromide 200 μg Bid Aclidinium Bromide 400 μg Bid Formoterol 12 μg Bid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/73 (5.48%)      4/73 (5.48%)      5/74 (6.76%)      2/74 (2.70%)      1/76 (1.32%)    
Nervous system disorders           
Headache  1  4/73 (5.48%)  4/73 (5.48%)  5/74 (6.76%)  2/74 (2.70%)  1/76 (1.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: AstraZeneca Clinical
Organization: Study Information Center
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01120093     History of Changes
Other Study ID Numbers: M/34273/29
LAS29
First Submitted: May 7, 2010
First Posted: May 10, 2010
Results First Submitted: August 14, 2012
Results First Posted: September 12, 2012
Last Update Posted: January 9, 2017