Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01462929
Last Updated: 2017-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
414 participants
INTERVENTIONAL
2011-11-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aclidinium bromide
Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment
Aclidinium bromide
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Tiotropium
Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment
Tiotropium
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
Placebo
Placebo comparator administered during 6 weeks of treatment
Placebo
Dosage form: Dry powder Route of administration: 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) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).
Interventions
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Aclidinium bromide
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Tiotropium
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
Placebo
Dosage form: Dry powder Route of administration: 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) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).
Eligibility Criteria
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Inclusion Criteria
* Post-salbutamol (FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
* Current or ex-smokers of 10 ≥pack-years.
Exclusion Criteria
* No evidence of an exacerbation within 6 weeks prior to the screening visit.
* No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
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 #9
Humpolec, , Czechia
Almirall Investigational Site #1
Jaroměř, , Czechia
Almirall Investigational Site #3
Mělník, , Czechia
Almirall Investigational Site #4
Berlin, , Germany
Almirall Investigational Site #12
Berlin, , Germany
Almirall Investigational Site #10
Berlin, , Germany
Almirall Investigational Site #8
Berlin, , Germany
Almirall Investigational Site #20
Berlin, , Germany
Almirall Investigational Site #21
Berlin, , Germany
Almirall Investigational Site #2
Berlin, , Germany
Almirall Investigational Site #24
Cologne, , Germany
Almirall Investigational Site #13
Dresden, , Germany
Almirall Investigational Site #9
Frankfurt, , Germany
Almirall Investigational Site #3
Großhansdorf, , Germany
Almirall Investigational Site #1
Hamburg, , Germany
Almirall Investigational Site #18
Hamburg, , Germany
Almirall Investigational Site #5
Hanover, , Germany
Almirall Investigational Site #22
Hanover, , Germany
Almirall Investigational Site #14
Jena, , Germany
Almirall Investigational Site #17
Lübeck, , Germany
Almirall Investigational Site #23
Rudersdorf, , Germany
Almirall Investigational Site #6
Schwerin, , Germany
Almirall Investigational Site #16
Wiesbaden, , Germany
Almirall Investigational Site #4
Debrecen, , Hungary
Almirall Investigational Site #2
Komárom, , Hungary
Almirall Investigational Site #3
Mátraháza, , Hungary
Almirall Investigational Site #1
Szarvas, , Hungary
Almirall Investigational Site #11
Szigetszentmiklós, , Hungary
Almirall Investigational Site #18
Bialystok, , Poland
Almirall Investigational Site #8
Bialystok, , Poland
Almirall Investigational Site #2
Elblag, , Poland
Almirall Investigational Site #17
Krakow, , Poland
Almirall Investigational Site #10
Krakow, , Poland
Almirall Investigational Site #16
Lodz, , Poland
Almirall Investigational Site #20
Lodz, , Poland
Almirall Investigational Site #4
Proszowice, , Poland
Almirall Investigational Site #6
Sopot, , Poland
Almirall Investigational Site #14
Tarnów, , Poland
Almirall Investigational Site #19
Warsaw, , Poland
Almirall Investigational Site #12
Wilkowice-Bystra, , Poland
Almirall Investigational Site #13
Wroclaw, , Poland
Countries
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References
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McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
Related Links
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Other Identifiers
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M/34273/39
Identifier Type: -
Identifier Source: org_study_id
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