Phase 3
Completed N=181
A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00500318 ↗
Enrolled (actual)
181
Serious AEs
2.8%
Results posted
Dec 2012
Primary outcomePrimary: Change From Baseline in Exercise Endurance Time (ET) — 129.45; 13.01 Seconds — p=0.0042
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Exercise Endurance Time (ET) |
129.45; 13.01 | 0.0042 sig |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) |
0.090; -0.010 | — |
| SECONDARY Trough Inspiratory Capacity (IC) |
0.083; -0.019 | — |
| SECONDARY Functional Residual Capacity (FRC) |
-0.138; -0.076 | — |
| SECONDARY Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio |
0.014; -0.003 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and = 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
Data sourced from ClinicalTrials.gov (NCT00500318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.