Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38) (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: November 4, 2015
Last verified: November 2015
  Purpose
The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. 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 will receive the higher Aclidinium Bromide during 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:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Change from baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)

  • Part B: Morning Predose (Trough) FEV1 [ Time Frame: Change from baseline (Week 0) to 52 Weeks ] [ Designated as safety issue: No ]
    Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)


Secondary Outcome Measures:
  • Part A: Peak Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Change from baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)

  • Part B: Peak FEV1 [ Time Frame: Change from baseline (Week 0) to 52 Weeks ] [ Designated as safety issue: No ]
    Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)


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 twice per day, 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, oral inhalation twice per day 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 of treatment.
Experimental: 2
Aclidinium bromide 400 μg dose twice per day, 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, oral inhalation twice per day 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 of treatment.
Placebo Comparator: 3
Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks
Drug: Placebo
Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2008; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
  • Current or former cigarette 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 per day
  • Patient with uncontrolled infection due to HIV and/or active hepatitis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics
  • Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
  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: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01045161     History of Changes
Other Study ID Numbers: LAS-MD-38 
Study First Received: January 7, 2010
Results First Received: August 14, 2012
Last Updated: November 4, 2015
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Anticonvulsants

ClinicalTrials.gov processed this record on July 26, 2016