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 has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01572792
First received: April 4, 2012
Last updated: June 30, 2013
Last verified: June 2013

April 4, 2012
June 30, 2013
April 2012
June 2013   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Adverse Events, Clinical Laboratory Parameters, Vital Sign Measurement, and electrocardiogram parameters
Same as current
Complete list of historical versions of study NCT01572792 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
909
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   New Zealand,   Australia
 
NCT01572792
LAC-MD-36
No
Forest Laboratories
Forest Laboratories
Almirall, S.A.
Study Director: Carrie D'Andrea, MS Forest Laboratories
Forest Laboratories
June 2013

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