Phase 3
Completed N=605
Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)
Source: ClinicalTrials.gov NCT01044459 ↗Enrolled (actual)
605
Serious AEs
9.6%
Results posted
Sep 2012
Primary outcomePrimary: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) — 0.034; 0.072 L
Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) |
0.034; 0.072 | — |
| SECONDARY Change From Baseline in Peak FEV1 |
0.185; 0.214 | — |
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, 2010; 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 (NCT01044459). 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.