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)
This study has been completed.
Sponsor:
Almirall, S.A.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01462929
First received: October 28, 2011
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Aclidinium bromide Drug: Tiotropium Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multiple Dose, Double-blind, Double-dummy, Placebo Controlled, Parallel Clinical Trial to Assess the Efficacy and Safety of Twice Daily Inhaled Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
Resource links provided by NLM:
Further study details as provided by Almirall, S.A.:
Primary Outcome Measures:
- Normalised FEV1 Area Under the Curve Over the 24-h Period [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment
Secondary Outcome Measures:
- Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment
| Enrollment: | 414 |
| Study Start Date: | November 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aclidinium bromide
Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment
|
Drug: 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)
|
|
Active Comparator: Tiotropium
Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment
|
Drug: 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 Comparator: Placebo
Placebo comparator administered during 6 weeks of treatment
|
Drug: 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| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
- 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:
- Patients with no history or current diagnosis of asthma.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462929
Locations
| Czech Republic | |
| Almirall Investigational Site #9 | |
| Humpolec, Czech Republic, 396 26 | |
| Almirall Investigational Site #1 | |
| Jaromer, Czech Republic, 551 01 | |
| Almirall Investigational Site #3 | |
| Melnik, Czech Republic, 276 01 | |
| Germany | |
| Almirall Investigational Site #21 | |
| Berlin, Germany, 14050 | |
| Almirall Investigational Site #2 | |
| Berlin, Germany, 14057 | |
| Almirall Investigational Site #8 | |
| Berlin, Germany, 13125 | |
| Almirall Investigational Site #4 | |
| Berlin, Germany, 10117 | |
| Almirall Investigational Site #12 | |
| Berlin, Germany, 10717 | |
| Almirall Investigational Site #10 | |
| Berlin, Germany, 10969 | |
| Almirall Investigational Site #20 | |
| Berlin, Germany, 13507 | |
| Almirall Investigational Site #13 | |
| Dresden, Germany | |
| Almirall Investigational Site #9 | |
| Frankfurt, Germany, 60596 | |
| Almirall Investigational Site #3 | |
| Grosshansdorf, Germany, 22927 | |
| Almirall Investigational Site #18 | |
| Hamburg, Germany, 22143 | |
| Almirall Investigational Site #1 | |
| Hamburg, Germany, 20253 | |
| Almirall Investigational Site #5 | |
| Hannover, Germany, 30159 | |
| Almirall Investigational Site #22 | |
| Hannover, Germany, 30625 | |
| Almirall Investigational Site #14 | |
| Jena, Germany, 07740 | |
| Almirall Investigational Site #24 | |
| Koln, Germany, 51069 | |
| Almirall Investigational Site #17 | |
| Lubeck, Germany, 23552 | |
| Almirall Investigational Site #23 | |
| Rudersdorf, Germany, 15562 | |
| Almirall Investigational Site #6 | |
| Schwerin, Germany, 19055 | |
| Almirall Investigational Site #16 | |
| Wiesbaden, Germany, 65187 | |
| Hungary | |
| Almirall Investigational Site #4 | |
| Debrecen, Hungary, 4043 | |
| Almirall Investigational Site #2 | |
| Komarom, Hungary, 2900 | |
| Almirall Investigational Site #3 | |
| Matrahaza, Hungary, 3233 | |
| Almirall Investigational Site #1 | |
| Szarvas, Hungary, 5540 | |
| Almirall Investigational Site #11 | |
| Szigetszentmiklos, Hungary, 2310 | |
| Poland | |
| Almirall Investigational Site #8 | |
| Bialystok, Poland, 15-540 | |
| Almirall Investigational Site #18 | |
| Bialystok, Poland, 15-540 | |
| Almirall Investigational Site #2 | |
| Elblag, Poland, 82-300 | |
| Almirall Investigational Site #10 | |
| Krakow, Poland, 31-455 | |
| Almirall Investigational Site #17 | |
| Krakow, Poland, 31-023 | |
| Almirall Investigational Site #16 | |
| Lodz, Poland, 90-153 | |
| Almirall Investigational Site #20 | |
| Lodz, Poland, 90-153 | |
| Almirall Investigational Site #4 | |
| Proszowice, Poland, 32-100 | |
| Almirall Investigational Site #6 | |
| Sopot, Poland, 84-741 | |
| Almirall Investigational Site #14 | |
| Tarnow, Poland, 33-100 | |
| Almirall Investigational Site #19 | |
| Warszawa, Poland, 01-138 | |
| Almirall Investigational Site #12 | |
| Wilkowice-Bystra, Poland, 43-365 | |
| Almirall Investigational Site #13 | |
| Wroclaw, Poland, 50-349 | |
Sponsors and Collaborators
Almirall, S.A.
Forest Laboratories
Investigators
| Study Director: | Estrella Garcia, Ph.D. | Almirall Global Clinical Operations & SR |
More Information
No publications provided
| Responsible Party: | Almirall, S.A. |
| ClinicalTrials.gov Identifier: | NCT01462929 History of Changes |
| Other Study ID Numbers: | M/34273/39 |
| Study First Received: | October 28, 2011 |
| Results First Received: | March 27, 2013 |
| Last Updated: | March 27, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Almirall, S.A.:
|
COPD antimuscarinic |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Bromides Tiotropium Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 18, 2013