Phase 3
Completed N=819
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Source: ClinicalTrials.gov NCT01001494 ↗Enrolled (actual)
819
Serious AEs
5.1%
Results posted
Sep 2012
Primary outcomePrimary: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment — 0.026; 0.055; -0.073 Liters
Summary
The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment |
0.026; 0.055; -0.073 | — |
| PRIMARY Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment |
0.030; 0.058; -0.047 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment |
0.206; 0.231; 0.022 | — |
| SECONDARY Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment |
53.3; 56.9; 45.5; 46.7; 43.1; 54.5 | — |
| SECONDARY Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment |
56.0; 57.3; 41.0; 44.0; 42.8; 59.0 | — |
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 (NCT01001494). 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.