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

AstraZeneca181 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

181

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Aclidinium BromideDRUG

Aclidinium Bromide, 200μg. Once daily oral inhalation.

PlaceboDRUG

Dose matched placebo, once daily oral inhalation.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (52)

Outcomes

Primary Outcomes

Change From Baseline in Exercise Endurance Time (ET)

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.

Time frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Secondary Outcomes

Trough Forced Expiratory Volume in 1 Second (FEV1)

Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).

Time frame: Change from baseline (Visit 4) at Week 6 (Visit 6)

Trough Inspiratory Capacity (IC)

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).

Time frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Functional Residual Capacity (FRC)

Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).

Time frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio

Ratio of trough Inspiratory Capacity verses Total Lung Capacity.

Time frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Data from ClinicalTrials.gov

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Forest Investigative Site 2088

Jasper, Alabama, United States

Forest Investigative Site 0909

Phoenix, Arizona, United States

Forest Investigative Site 0957

Long Beach, California, United States

Forest Investigative Site 0973

Los Angeles, California, United States

Forest Investigative Site 0887

Los Angeles, California, United States

Forest Investigative Site 0988

Sacramento, California, United States

Forest Investigative Site 0885

Torrance, California, United States

Forest Investigative Site 2663

Clearwater, Florida, United States

Forest Investigative Site 1030

Jacksonville, Florida, United States

Forest Investigative Site 0974

Pensacola, Florida, United States

...and 42 more locations