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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:
ClinicalTrials.gov Identifier:
NCT01462929
First Posted: November 1, 2011
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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 (COPD) Drug: Aclidinium bromide Drug: Tiotropium Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 AstraZeneca:

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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 #4
Berlin, Germany, 10117
Almirall Investigational Site #12
Berlin, Germany, 10717
Almirall Investigational Site #10
Berlin, Germany, 10969
Almirall Investigational Site #8
Berlin, Germany, 13125
Almirall Investigational Site #20
Berlin, Germany, 13507
Almirall Investigational Site #21
Berlin, Germany, 14050
Almirall Investigational Site #2
Berlin, Germany, 14057
Almirall Investigational Site #13
Dresden, Germany
Almirall Investigational Site #9
Frankfurt, Germany, 60596
Almirall Investigational Site #3
Grosshansdorf, Germany, 22927
Almirall Investigational Site #1
Hamburg, Germany, 20253
Almirall Investigational Site #18
Hamburg, Germany, 22143
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 #18
Bialystok, Poland, 15-540
Almirall Investigational Site #8
Bialystok, Poland, 15-540
Almirall Investigational Site #2
Elblag, Poland, 82-300
Almirall Investigational Site #17
Krakow, Poland, 31-023
Almirall Investigational Site #10
Krakow, Poland, 31-455
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
AstraZeneca
Investigators
Study Director: Esther Garcia, Ph.D. AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01462929     History of Changes
Other Study ID Numbers: M/34273/39
First Submitted: October 28, 2011
First Posted: November 1, 2011
Results First Submitted: March 27, 2013
Results First Posted: May 22, 2013
Last Update Posted: January 4, 2017
Last Verified: November 2016

Keywords provided by AstraZeneca:
COPD
antimuscarinic

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bromides
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
Anticonvulsants