Phase 3
Completed N=544
Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)
Source: ClinicalTrials.gov NCT01045161 ↗Enrolled (actual)
544
Serious AEs
8.1%
Results posted
Dec 2015
Primary outcomePrimary: Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) — -0.008; 0.043; 0.064 L — p=0.019
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) |
-0.008; 0.043; 0.064 | 0.019 sig |
| PRIMARY Part B: Morning Predose (Trough) FEV1 |
0.045; 0.029; 0.048 | 0.0192 sig |
| SECONDARY Part A: Peak Forced Expiratory Volume in 1 Second (FEV1) |
0.087; 0.202; 0.212 | — |
| SECONDARY Part B: Peak FEV1 |
0.185; 0.176; 0.172 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2008; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
- Current or former cigarette smokers
Exclusion Criteria
- Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
- Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
- Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
- History or presence of asthma verified from medical records
- Chronic use of oxygen therapy greater than or equal to 15 hours per day
- Patient with uncontrolled infection due to HIV and/or active hepatitis
- Patients with a history of hypersensitivity reaction to inhaled anticholinergics
- Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
Data sourced from ClinicalTrials.gov (NCT01045161). 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.