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Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01044459
First received: January 5, 2010
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: aclidinium bromide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) [ Time Frame: From baseline to 52 weeks ] [ Designated as safety issue: No ]
    Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.


Secondary Outcome Measures:
  • Change From Baseline in Peak FEV1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change From Baseline in Peak FEV1 in liters at Week 52.


Enrollment: 605
Study Start Date: November 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
aclidinium bromide, inhaled, 52 weeks of treatment
 Drug: aclidinium bromide
aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Experimental: 2
aclidinium bromide, inhaled, 52 weeks of treatment
 Drug: aclidinium bromide
aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

  Eligibility

Ages Eligible for Study:   40 Years and older
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, 2010; 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044459

  Show 113 Study Locations
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Jordan Lateiner, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01044459     History of Changes
Other Study ID Numbers: LAS-MD-35
Study First Received: January 5, 2010
Results First Received: August 14, 2012
Last Updated: August 14, 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 May 22, 2013