Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)

Phase 3

Completed

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

• Registration Number: NCT01045161
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Disposition First Submitted: 2012-01-05
• Disposition First Submitted QC: 2012-01-05
• Disposition First Posted: 2012-01-09
• Results First Submitted: 2012-08-14
• Results First Submitted QC: 2015-11-04
• Results First Posted: 2015-12-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 544

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks
1	Aclidinium bromide	Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks
2	Aclidinium bromide	Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks

Primary Outcome Measures

Name	Time	Method
Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)	Change from baseline (Week 0) to Week 12	Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Part B: Morning Predose (Trough) FEV1	Change from baseline (Week 0) to 52 Weeks	Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)

Secondary Outcome Measures

Name	Time	Method
Part B: Peak FEV1	Change from baseline (Week 0) to 52 Weeks	Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)
Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)	Change from baseline (Week 0) to Week 12	Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)

Trial Locations

Locations (112)

Forest Investigative Site 1493; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 1419; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 1413; 🇺🇸 Muscle Shoals, Alabama, United States

Forest Investigative Site 1353; 🇺🇸 Pell City, Alabama, United States

Forest Investigative Site 1379; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 2065; 🇺🇸 Fullerton, California, United States

Forest Investigative Site 1451; 🇺🇸 National City, California, United States

Forest Investigative Site 1388; 🇺🇸 Paramount, California, United States

Forest Investigative Site 1424; 🇺🇸 Rolling Hill Estates, California, United States

Forest Investigative Site 1427; 🇺🇸 Sacramento, California, United States

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