Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

Phase 3

Completed

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

• Registration Number: NCT00970268
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Disposition First Submitted: 2011-10-04
• Disposition First Submitted QC: 2011-10-04
• Disposition First Posted: 2011-10-06
• Results First Submitted: 2012-08-14
• Results First Submitted QC: 2012-08-14
• Results First Posted: 2012-09-14
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

• Completion of a lead-in study (NCT00891462)

Exclusion Criteria

• Use or anticipated use of any medication prohibited in this study
• Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
• The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
• QTcB of >500 msec on both the pre-dose and post-dose ECG
• Women who are pregnant, intend to become pregnant, or are breast-feeding
• A life expectancy of less than 1 year
• Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
• Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aclidinium bromide	Aclidinium bromide dose, inhaled, for 52 weeks of treatment
2	Aclidinium bromide	Aclidinium bromide dose, inhaled, for 52 weeks of treatment

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)	Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks	Change From Baseline (Visit 2 of lead-in Study NCT00891462, \[LAS-MD-33\]) to Week 52 (Week 64 From Start of NCT00891462, \[LAS-MD-33\]) in Morning Predose (Trough) FEV1

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Peak FEV1	52 weeks	Change From Baseline (Visit 2 of study NCT00891462, \[LAS-MD-33\])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, \[LAS-MD-33\]).

Trial Locations

Locations (83)

Forest Investigative Site 1162; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 1127; 🇺🇸 Mobile, Alabama, United States

Forest Investigative Site 0909; 🇺🇸 Glendale, Arizona, United States

Forest Investigative Site 2060; 🇺🇸 Phoenix, Arizona, United States

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

Forest Investigative Site 1088; 🇺🇸 Lakewood, California, United States

Forest Investigative Site 1122; 🇺🇸 Orange, California, United States

Forest Investigative Site 2029; 🇺🇸 Rancho Mirage, California, United States

Forets Investigative Site 2064; 🇺🇸 Riverside, California, United States

Forest Investigative Site 0517; 🇺🇸 Sacramento, California, United States

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