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:
Forest Laboratories
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
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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:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Formic acid
Formoterol fumarate
Formoterol
Arformoterol Tartrate
Aclidinium bromide
U.S. FDA Resources
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
| Estimated Enrollment: | 1240 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated 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
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| Anniston, Alabama, United States, 36207 | |
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| Wellington, New Zealand, 7366 | |
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: | April 5, 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 May 21, 2013