Phase 3
Completed N=414
Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01462929 ↗Enrolled (actual)
414
Serious AEs
1.7%
Results posted
May 2013
Primary outcomePrimary: Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment — 0.065; 0.055; -0.085 Liters
Summary
The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment |
0.065; 0.055; -0.085 | — |
| SECONDARY Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment |
0.032; -0.006; -0.128 | — |
Eligibility Criteria
Inclusion Criteria
- Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
- Post-salbutamol (FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
- Current or ex-smokers of 10 ≥pack-years.
Exclusion Criteria
- Patients with no history or current diagnosis of asthma.
- No evidence of an exacerbation within 6 weeks prior to the screening visit.
- No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
- No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Data sourced from ClinicalTrials.gov (NCT01462929). 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.