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NCT Number: NCT00500318

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Attributes Emphysema Graft vs Host Disease Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site 0968, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aclidinium Bromide

Drug

Aclidinium Bromide, 200μg. Once daily oral inhalation.

Placebo

Drug

Dose matched placebo, once daily oral inhalation.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Jul 12, 2007
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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