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)

This study has been completed.

Sponsor:

Collaborator:

Almirall, S.A.

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00970268

First received: September 1, 2009

Last updated: August 14, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2009

Last Updated Date

August 14, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Change from Baseline (Visit 2 of lead-in study LAS-MD-33) to week 52 (Week 64 from start of LAS-MD-33) in morning predose (trough) FEV1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00970268 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change From Baseline in Peak FEV1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

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]).

Original Secondary Outcome Measures ^ICMJE

Change from Baseline (Visit 2 of LAS-MD-33) to week 52 (Week 64 from start of LAS-MD-33) in peak FEV1. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Drug: Aclidinium bromide
Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Study Arm (s)

Experimental: 1
Aclidinium bromide dose, inhaled, for 52 weeks of treatment

Intervention: Drug: Aclidinium bromide
Experimental: 2
Aclidinium bromide dose, inhaled, for 52 weeks of treatment

Intervention: Drug: Aclidinium bromide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

291

Completion Date

Not Provided

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00970268

Other Study ID Numbers ^ICMJE

LAS-MD-36

Has Data Monitoring Committee

Responsible Party

Forest Laboratories

Study Sponsor ^ICMJE

Forest Laboratories

Collaborators ^ICMJE

Almirall, S.A.

Investigators ^ICMJE

Study Director:

Jordan Lateiner, MS

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Information Provided By

Forest Laboratories

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top