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)

November 16, 2016 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

414

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Humpolec, Czech Republic, 396 26
        • Almirall Investigational Site #9
      • Jaromer, Czech Republic, 551 01
        • Almirall Investigational Site #1
      • Melnik, Czech Republic, 276 01
        • Almirall Investigational Site #3
  • Germany
      • Berlin, Germany, 10117
        • Almirall Investigational Site #4
      • Berlin, Germany, 10717
        • Almirall Investigational Site #12
      • Berlin, Germany, 10969
        • Almirall Investigational Site #10
      • Berlin, Germany, 13125
        • Almirall Investigational Site #8
      • Berlin, Germany, 13507
        • Almirall Investigational Site #20
      • Berlin, Germany, 14050
        • Almirall Investigational Site #21
      • Berlin, Germany, 14057
        • Almirall Investigational Site #2
      • Dresden, Germany
        • Almirall Investigational Site #13
      • Frankfurt, Germany, 60596
        • Almirall Investigational Site #9
      • Grosshansdorf, Germany, 22927
        • Almirall Investigational Site #3
      • Hamburg, Germany, 20253
        • Almirall Investigational Site #1
      • Hamburg, Germany, 22143
        • Almirall Investigational Site #18
      • Hannover, Germany, 30159
        • Almirall Investigational Site #5
      • Hannover, Germany, 30625
        • Almirall Investigational Site #22
      • Jena, Germany, 07740
        • Almirall Investigational Site #14
      • Koln, Germany, 51069
        • Almirall Investigational Site #24
      • Lubeck, Germany, 23552
        • Almirall Investigational Site #17
      • Rudersdorf, Germany, 15562
        • Almirall Investigational Site #23
      • Schwerin, Germany, 19055
        • Almirall Investigational Site #6
      • Wiesbaden, Germany, 65187
        • Almirall Investigational Site #16
  • Hungary
      • Debrecen, Hungary, 4043
        • Almirall Investigational Site #4
      • Komarom, Hungary, 2900
        • Almirall Investigational Site #2
      • Matrahaza, Hungary, 3233
        • Almirall Investigational Site #3
      • Szarvas, Hungary, 5540
        • Almirall Investigational Site #1
      • Szigetszentmiklos, Hungary, 2310
        • Almirall Investigational Site #11
  • Poland
      • Bialystok, Poland, 15-540
        • Almirall Investigational Site #18
      • Bialystok, Poland, 15-540
        • Almirall Investigational Site #8
      • Elblag, Poland, 82-300
        • Almirall Investigational Site #2
      • Krakow, Poland, 31-023
        • Almirall Investigational Site #17
      • Krakow, Poland, 31-455
        • Almirall Investigational Site #10
      • Lodz, Poland, 90-153
        • Almirall Investigational Site #16
      • Lodz, Poland, 90-153
        • Almirall Investigational Site #20
      • Proszowice, Poland, 32-100
        • Almirall Investigational Site #4
      • Sopot, Poland, 84-741
        • Almirall Investigational Site #6
      • Tarnow, Poland, 33-100
        • Almirall Investigational Site #14
      • Warszawa, Poland, 01-138
        • Almirall Investigational Site #19
      • Wilkowice-Bystra, Poland, 43-365
        • Almirall Investigational Site #12
      • Wroclaw, Poland, 50-349
        • Almirall Investigational Site #13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

October 31, 2011

First Posted (Estimate)

November 1, 2011

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M/34273/39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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