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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2008

Interventions

  • Drug: Aclidinium Bromide
    • Aclidinium Bromide, 200μg. Once daily oral inhalation.
  • Drug: Placebo
    • Dose matched placebo, once daily oral inhalation.

Arms, Groups and Cohorts

  • Experimental: Aclidinium
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Esther Garcia, MD, Study Director, AstraZeneca

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