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To Assess the Long-term Safety, Efficacy and Tolerability of Inhaled Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01045161
First received: January 7, 2010
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy, safety and tolerability of two doses of inhaled aclidinium bromide compared with placebo for 12 weeks in patients with moderate to severe, stable chronic obstructive pulmonary disease, followed by a 40 week evaluation of the higher Aclidinium Bromide dose. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients all patients will receive Aclidinium Bromide 400µg BID for the 40-week open label treatment period.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: Aclidinium bromide
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak Forced Expiratory Volume in 1 Second at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 544
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aclidinium bromide 200 μg dose BID, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks
 Drug: Aclidinium bromide
Aclidinium bromide 200 μg dose BID, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks
Experimental: 2
Aclidinium bromide 400 μg dose BID, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks
 Drug: Aclidinium bromide
Aclidinium bromide 400 μg dose BID, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks
Placebo Comparator: 3
Inhaled placebo for 12 weeks. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks
 Drug: Placebo
Inhaled placebo for 12 weeks. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of stable, moderate to severe COPD as defined by the GOLD guidelines and stable airway obstruction
  • Current or former smokers

Exclusion Criteria:

  • Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
  • Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
  • Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
  • History or presence of asthma verified from medical records
  • Chronic use of oxygen therapy greater than or equal to 15 hours/day
  • Patient with uncontrolled infection due to HIV and/or active hepatitis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045161

  Show 112 Study Locations
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Brian T. Maurer, M.S. Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01045161     History of Changes
Other Study ID Numbers: LAS-MD-38
Study First Received: January 7, 2010
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Forest Laboratories:
Chronic Obstructive Pulmonary Disease
COPD
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
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013