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
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium Bromide/Formoterol Fumarate
Drug: Aclidinium Bromide
Drug: Formoterol Fumarate
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    Adverse Events, Clinical Laboratory Parameters, Vital Sign Measurement, and electrocardiogram parameters


Enrollment: 909
Study Start Date: April 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aclidinium/formoterol Fixed-Dose Combination (FDC) high dose
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled Aclidinium/formoterol FDC high dose, twice per day
Experimental: 2
Aclidinium/formoterol FDC low dose, twice per day
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled Aclidinium/formoterol FDC high dose, twice per day
Active Comparator: 3
Aclidinium monotherapy 400 μg
Drug: Aclidinium Bromide
Inhaled Aclidinium 400 μg, twice per day
Active Comparator: 4
Formoterol monotherapy 12 μg
Drug: Formoterol Fumarate
Inhaled Formoterol 12 μg, twice per day
Placebo Comparator: 5
Placebo
Drug: Placebo
Inhaled dose-matched placebo, twice per day

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572792

  Show 208 Study Locations
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Carrie D'Andrea, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01572792     History of Changes
Other Study ID Numbers: LAC-MD-36
Study First Received: April 4, 2012
Last Updated: June 30, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Forest Laboratories:
COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Formoterol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 17, 2014