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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 28, 2014