Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Aclidinium bromide; Drug: Placebo

• Registration Number: NCT00891462
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Disposition First Submitted: 2011-09-30
• Disposition First Submitted QC: 2011-09-30
• Disposition First Posted: 2011-10-05
• Results First Submitted: 2012-08-14
• Results First Submitted QC: 2012-08-14
• Results First Posted: 2012-09-13
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 561

Inclusion Criteria

• A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Aclidinium bromide	Aclidinium bromide dose, inhaled, for 12 weeks of treatment
3	Placebo	Inhaled placebo for 12 weeks
1	Aclidinium bromide	Aclidinium bromide dose, inhaled, for 12 weeks of treatment

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)	Change from Baseline to 12 weeks	Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)	Change from Baseline to 12 weeks	Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)

Trial Locations

Locations (1)

Forest Investigative Site; 🇨🇦 Toronto, Canada