Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Almirall, S.A.

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT01572792

First received: April 4, 2012

Last updated: April 5, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 4, 2012

Last Updated Date

April 5, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Adverse Events, Clinical Laboratory Parameters, Vital Sign Measurement, and electrocardiogram parameters

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01572792 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Official Title ^ICMJE

A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Brief Summary

The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.

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/Formoterol Fumarate
Inhaled Aclidinium/formoterol FDC high dose, twice per day
Drug: Aclidinium Bromide
Inhaled Aclidinium 400 μg, twice per day
Drug: Formoterol Fumarate
Inhaled Formoterol 12 μg, twice per day
Drug: Placebo
Inhaled dose-matched placebo, twice per day

Study Arm (s)

Experimental: 1
Aclidinium/formoterol Fixed-Dose Combination (FDC) high dose

Intervention: Drug: Aclidinium Bromide/Formoterol Fumarate
Experimental: 2
Aclidinium/formoterol FDC low dose, twice per day

Intervention: Drug: Aclidinium Bromide/Formoterol Fumarate
Active Comparator: 3
Aclidinium monotherapy 400 μg

Intervention: Drug: Aclidinium Bromide
Active Comparator: 4
Formoterol monotherapy 12 μg

Intervention: Drug: Formoterol Fumarate
Placebo Comparator: 5
Placebo

Intervention: Drug: Placebo

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

Enrolling by invitation

Estimated Enrollment ^ICMJE

1240

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Completion of the treatment phase of the lead-in study, LAC-MD-31
Written informed consent obtained from the patient before the initiation of any study specific procedures
No medical contraindication as judged by the PI
Compliance with LAC-MD-31 study procedures and IP dosing.

Exclusion Criteria:

No specific exclusion criteria

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, Australia, Canada, New Zealand

Administrative Information

NCT Number ^ICMJE

NCT01572792

Other Study ID Numbers ^ICMJE

LAC-MD-36

Has Data Monitoring Committee

Responsible Party

Forest Laboratories

Study Sponsor ^ICMJE

Forest Laboratories

Collaborators ^ICMJE

Almirall, S.A.

Investigators ^ICMJE

Study Director:

Carrie D'Andrea, MS

Forest Laboratories

Information Provided By

Forest Laboratories

Verification Date

April 2013

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

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