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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500318
First Posted: July 12, 2007
Last Update Posted: January 6, 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
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.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: Aclidinium Bromide Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).

  • 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).

  • 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).

  • 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.


Enrollment: 181
Study Start Date: July 2007
Study Completion Date: September 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aclidinium Drug: Aclidinium Bromide
Aclidinium Bromide, 200μg. Once daily oral inhalation.
Placebo Comparator: Placebo Drug: Placebo
Dose matched placebo, once daily oral inhalation.

  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:

  • 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
  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): NCT00500318


  Show 52 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Esther Garcia, MD AstraZeneca
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00500318     History of Changes
Other Study ID Numbers: LAS-MD-CL26
First Submitted: July 10, 2007
First Posted: July 12, 2007
Results First Submitted: August 14, 2012
Results First Posted: December 17, 2012
Last Update Posted: January 6, 2017
Last Verified: November 2016

Keywords provided by AstraZeneca:
Bronchitis, Chronic; Emphysema

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Bromides
Anticonvulsants