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:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01462929
First received: October 28, 2011
Last updated: July 25, 2013
Last verified: July 2013
  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:
  • Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment [ 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. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.


Secondary Outcome Measures:
  • Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment [ 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. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 25, 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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014