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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:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00500318
First received: July 10, 2007
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  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: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change From Baseline in Exercise Endurance Time (ET) [ Time Frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Ratio of trough Inspiratory Capacity verses Total Lung Capacity.


Enrollment: 181
Study Start Date: July 2007
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500318

  Show 52 Study Locations
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Brian T Maurer, M.S. Forest Laboratories
  More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00500318     History of Changes
Other Study ID Numbers: LAS-MD-CL26
Study First Received: July 10, 2007
Results First Received: August 14, 2012
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Forest Laboratories:
Bronchitis, Chronic; Emphysema

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
 Respiratory Tract Diseases
Bromides
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013