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 ID: NCT01471171
Last Updated: 2017-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
112 participants
INTERVENTIONAL
2011-11-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Aclidinium bromide
3-week treatment periods
Aclidinium Bromide
1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Placebo
3-week treatment periods
Placebo
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)
Interventions
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Aclidinium Bromide
1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Placebo
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)
Eligibility Criteria
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Inclusion Criteria
* Post-salbutamol Forced Expiratory Volume in one second(FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) \< 70%.
* Current or ex-smokers of ≥ 10 pack-years
* Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value
Exclusion Criteria
* Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
* Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
* Patients with an oxygen saturation \< 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
* Contra-indications of cardiopulmonary exercise testing.
* Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Esther Garcia, Ph.D.
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Almirall Investigational Site #10
Berlin, , Germany
Almirall Investigational Site #6
Berlin, , Germany
Almirall Investigational Site #2
Berlin, , Germany
Almirall Investigational Site #4
Frankfurt, , Germany
Almirall Investigational Site #5
Großhansdorf, , Germany
Almirall Investigational Site #8
Hamburg, , Germany
Almirall Investigational Site #9
Hamburg, , Germany
Almirall Investigational Site #3
Hanover, , Germany
Almirall Investigational Site #7
Lübeck, , Germany
Almirall Investigational Site #1
Wiesbaden, , Germany
Almirall Investigational Site #1
Alicante, , Spain
Almirall Investigational Site #4
Barcelona, , Spain
Almirall Investigational Site #2
Madrid, , Spain
Almirall Investigational Site #2
London, , United Kingdom
Countries
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References
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Beeh KM, Watz H, Puente-Maestu L, de Teresa L, Jarreta D, Caracta C, Garcia Gil E, Magnussen H. Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial. BMC Pulm Med. 2014 Dec 23;14:209. doi: 10.1186/1471-2466-14-209.
Related Links
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Other Identifiers
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M/34273/40
Identifier Type: -
Identifier Source: org_study_id
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