Phase 3
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
Bottom Line
View on ClinicalTrials.gov: NCT00500318 ↗Enrolled (actual)
181
Serious AEs
2.8%
Results posted
Dec 2012
Primary outcome: Primary: Change From Baseline in Exercise Endurance Time (ET) — 129.45; 13.01 Seconds — p=0.0042
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aclidinium Bromide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2008
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 | — |
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.
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.