A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

November 16, 2016 updated by: AstraZeneca

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD

This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

181

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Forest Investigative Site 0968
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1E4
        • Forest Investigative Site 0960
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Forest Investigative Site 0905
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • Forest Investigative Site 0976
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Forest Investigative Site 0891
      • Ottawa, Ontario, Canada, K1Y4E9
        • Forest Investigative Site 2204
      • Windsor, Ontario, Canada, N8X 3V6
        • Forest Investigative Site 0969
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Forest Investigative Site 2205
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • Forest Investigative Site 0893
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Forest Investigative Site 0943
  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
        • Forest Investigative Site 2088
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Forest Investigative Site 0909
    • California
      • Long Beach, California, United States, 90822
        • Forest Investigative Site 0957
      • Los Angeles, California, United States, 90095-1690
        • Forest Investigative Site 0887
      • Los Angeles,, California, United States, 90073
        • Forest Investigative Site 0973
      • Sacramento, California, United States, 95817
        • Forest Investigative Site 0988
      • Torrance, California, United States, 90502
        • Forest Investigative Site 0885
    • Florida
      • Clearwater, Florida, United States, 33756
        • Forest Investigative Site 2663
      • Jacksonville, Florida, United States, 32224
        • Forest Investigative Site 1030
      • Pensacola, Florida, United States, 32504
        • Forest Investigative Site 0974
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Forest Investigative Site 0980
      • Atlanta, Georgia, United States, 30342
        • Forest Investigative Site 0991
      • Austell, Georgia, United States, 30106
        • Forest Investigative Site 0987
      • Marietta, Georgia, United States, 30060
        • Forest Investigative Site 2008
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Forest Investigative Site 0984
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Forest Investigative Site 1080
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Forest Investigative Site 0898
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Forest Investigative Site 0886
      • N. Dartmouth, Massachusetts, United States, 02747
        • Forest Investigative Site 1029
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Forest Investigative Site 0889
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Forest Investigative Site 2079
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2465
        • Forest Investigative Site 2071
    • New York
      • Brooklyn, New York, United States, 11229
        • Forest Investigative Site 0972
      • Great Neck, New York, United States, 11023
        • Forest Investigative Site 0971
      • New York, New York, United States, 10001
        • Forest Investigative Site 1114
      • New York, New York, United States, 10010-7436
        • Forest Investigative Site 2665
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Forest Investigative Site 2081
      • Charlotte, North Carolina, United States, 28262
        • Forest Investigative Site 0688
    • Ohio
      • Toledo, Ohio, United States, 43614
        • Forest Investigative Site 0981
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Forest Investigative Site 1057
      • Philadelphia, Pennsylvania, United States, 19140
        • Forest Investigative Site 0888
      • Scranton, Pennsylvania, United States, 18509
        • Forest Investigative Site 0983
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Forest Investigative Site 2072
      • Columbia, South Carolina, United States, 29201
        • Forest Investigative Site 1107
      • Columbia, South Carolina, United States, 29203
        • Forest Investigative Site 0979
      • Greenville, South Carolina, United States, 29615
        • Forest Investigative Site 1078
      • Spartanburg, South Carolina, United States, 29303
        • Forest Investigative Site 0900
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2650
        • Forest Investigative Site 0962
    • Texas
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 1082
      • Dallas, Texas, United States, 75246
        • Forest Investigative Site 2058
      • Houston, Texas, United States, 77030
        • Forest Investigative Site 0890
    • Utah
      • Midvale, Utah, United States, 84047
        • Forest Investigative Site 0977

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:

  • A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted
  • Current or former cigarette smoker
  • Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value
  • Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

Exclusion Criteria:

  • History of presence of asthma, allergic rhinitis, or atopy
  • Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
  • Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
  • Clinically significant respiratory conditions other than COPD
  • Chronic use of oxygen therapy >= 15 hours a day

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Dose matched placebo, once daily oral inhalation.
Experimental: Aclidinium
Drug: Aclidinium Bromide
Aclidinium Bromide, 200μg. Once daily oral inhalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Exercise Endurance Time (ET)
Time Frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
From baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Change from baseline (Visit 4) at Week 6 (Visit 6)
Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).
Change from baseline (Visit 4) at Week 6 (Visit 6)
Trough Inspiratory Capacity (IC)
Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).
Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Functional Residual Capacity (FRC)
Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).
Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio
Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Ratio of trough Inspiratory Capacity verses Total Lung Capacity.
Change from baseline Week 0 (Visit 4) to Week 6 (Visit 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

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

July 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 10, 2007

First Submitted That Met QC Criteria

July 10, 2007

First Posted (Estimate)

July 12, 2007

Study Record Updates

Last Update Posted (Estimate)

January 6, 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

  • LAS-MD-CL26

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.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Aclidinium Bromide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe