Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891462
• Other study ID #: LAS-MD-33
• Secondary ID: ACCORD COPD I
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2009
• Last updated: August 14, 2012
• Start date: April 2009
• Est. completion date: November 2009

Study information

• Verified date: August 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium bromide
Aclidinium bromide 200 µg, oral inhalation twice per day for 12 weeks of treatment
• Aclidinium bromide
Aclidinium bromide 400 µg, oral inhalation twice per day for 12 weeks of treatment
• Placebo
Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment

Locations

Country	Name	City	State
Canada	Forest Investigative Site	Edmonton	Alberta
Canada	Forest Investigative Site	Hamilton	Ontario
Canada	Forest Investigative Site	Kelowna	British Columbia
Canada	Forest Investigative Site	Niagara Falls	Ontario
Canada	Forest Investigative Site	Sainte-Foy	Quebec
Canada	Forest Investigative Site	Saskatoon	Saskatchewan
Canada	Forest Investigative Site	Toronto	Ontario
Canada	Forest Investigative Site	Toronto	Ontario
United States	Forest Investigative Site	Anaheim	California
United States	Forest Investigative Site	Asheville	North Carolina
United States	Forest Investigative Site	Austell	Georgia
United States	Forest Investigative Site	Baltimore	Maryland
United States	Forest Investigative Site	Baltimore	Maryland
United States	Forest Investigative Site	Bangor	Maine
United States	Forest Investigative Site	Bellingham	Washington
United States	Forest Investigative Site	Berlin	New Jersey
United States	Forest Investigative Site	Bethlehem	Pennsylvania
United States	Forest Investigative Site	Billings	Montana
United States	Forest Investigative Site	Birmingham	Alabama
United States	Forest Investigative Site	Blue Ridge	Georgia
United States	Forest Investigative Site	Brandon	Florida
United States	Forest Investigative Site	Brooklyn	New York
United States	Forest Investigative Site	Buffalo	New York
United States	Forest Investigative Site	Butte	Montana
United States	Forest Investigative Site	Canton	Ohio
United States	Forest Investigative Site	Charleston	South Carolina
United States	Forest Investigative Site	Charlotte	North Carolina
United States	Forest Investigative Site	Cincinnati	Ohio
United States	Forest Investigative Site	Cincinnati	Ohio
United States	Forest Investigative Site	Cincinnati	Ohio
United States	Forest Investigative Site	Clearwater	Florida
United States	Forest Investigative Site	Colorado Springs	Colorado
United States	Forest Investigative Site	Columbus	Ohio
United States	Forest Investigative Site	Crescent Springs	Kentucky
United States	Forest Investigative Site	Dallas	Texas
United States	Forest Investigative Site	Dallas	Texas
United States	Forest Investigative Site	DeLand	Florida
United States	Forest Investigative Site	Denver	Colorado
United States	Forest Investigative Site	Duluth	Georgia
United States	Forest Investigative Site	East Providence	Rhode Island
United States	Forest Investigative Site	Edina	Minnesota
United States	Forest Investigative Site	Encinitas	California
United States	Forest Investigative Site	Erie	Pennsylvania
United States	Forest Investigative Site	Florissant	Missouri
United States	Forest Investigative Site	Fort Lauderdale	Florida
United States	Forest Investigative Site	Fort Worth	Texas
United States	Forest Investigative Site	Fresno	California
United States	Forest Investigative Site	Fullerton	California
United States	Forest Investigative Site	Great Neck	New York
United States	Forest Investigative Site	Greenville	South Carolina
United States	Forest Investigative Site	Greer	South Carolina
United States	Forest Investigative Site	Hagerstown	Maryland
United States	Forest Investigative Site	Hershey	Pennsylvania
United States	Forest Investigative Site	Houston	Texas
United States	Forest Investigative Site	Ithaca	New York
United States	Forest Investigative Site	Jasper	Alabama
United States	Forest Investigative Site	Johnston	Rhode Island
United States	Forest Investigative Site	Lafayette	Louisiana
United States	Forest Investigative Site	Lakewood	California
United States	Forest Investigative Site	Lexington	Kentucky
United States	Forest Investigative Site	Livonia	Michigan
United States	Forest Investigative Site	Marietta	Georgia
United States	Forest Investigative Site	Medford	Oregon
United States	Forest Investigative Site	Melbourne	Florida
United States	Forest Investigative Site	Melbourne	Florida
United States	Forest Investigative Site	Mesa	Arizona
United States	Forest Investigative Site	Midvale	Utah
United States	Forest Investigative Site	Milwaukee	Wisconsin
United States	Forest Investigative Site	Minneapolis	Minnesota
United States	Forest Investigative Site	Minneapolis	Minnesota
United States	Forest Investigative Site	Mobile	Alabama
United States	Forest Investigative Site	Nashville	Tennessee
United States	Forest Investigative Site	New Hyde Park	New York
United States	Forest Investigative Site	New York	New York
United States	Forest Investigative Site	New York	New York
United States	Forest Investigative Site	North Dartmouth	Massachusetts
United States	Forest Investigative Site	Oklahoma City	Oklahoma
United States	Forest Investigative Site	Orange	California
United States	Forest Investigative Site	Ormond Beach	Florida
United States	Forest Investigative Site	Palo Alto	California
United States	Forest Investigative Site	Panama City	Florida
United States	Forest Investigative Site	Papillion	Nebraska
United States	Forest Investigative Site	Pensacola	Florida
United States	Forest Investigative Site	Phoenix	Arizona
United States	Forest Investigative Site	Phoenix	Arizona
United States	Forest Investigative Site	Pittsburgh	Pennsylvania
United States	Forest Investigative Site	Portland	Oregon
United States	Forest Investigative Site	Raleigh	North Carolina
United States	Forest Investigative Site	Rancho Mirage	California
United States	Forest Investigative Site	Richmond	Virginia
United States	Forest Investigative Site	Richmond	Virginia
United States	Forest Investigative Site	River Forest	Illinois
United States	Forest Investigative Site	Sacramento	California
United States	Forest Investigative Site	San Antonio	Texas
United States	Forest Investigative Site	San Diego	California
United States	Forest Investigative Site	San Diego	California
United States	Forest Investigative Site	Skokie	Illinois
United States	Forest Investigative Site	South Bend	Indiana
United States	Forest Investigative Site	Spartanburg	South Carolina
United States	Forest Investigative Site	Spokane	Washington
United States	Forest Investigative Site	St. Charles	Missouri
United States	Forest Investigative Site	Summit	New Jersey
United States	Forest Investigative Site	Tacoma	Washington
United States	Forest Investigative Site	Tamarac	Florida
United States	Forest Investigative Site	Tampa	Florida
United States	Forest Investigative Site	Tampa	Florida
United States	Forest Investigative Site	Toledo	Ohio
United States	Forest Investigative Site	Tyler	Texas
United States	Forest Investigative Site	Upland	Pennsylvania
United States	Forest Investigative Site	Waco	Texas
United States	Forest Investigative Site	Waterbury	Connecticut
United States	Forest Investigative Site	Wheat Ridge	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Almirall, S.A.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)	Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)	Change from Baseline to 12 weeks	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)	Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)	Change from Baseline to 12 weeks	No