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

Chronic Obstructive Pulmonary Disease Clinical Trial

— LAS-MD-35  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044459
• Other study ID #: LAS-MD-35
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2010
• Last updated: August 14, 2012
• Start date: November 2009
• Est. completion date: April 2011

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• 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, 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety 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 52 weeks of treatment
• aclidinium bromide
aclidinium bromide 400 µg, oral inhalation twice per day for 52 weeks of treatment

Locations

Country	Name	City	State
Canada	Forest Investigative Site 2201	Kelowna	British Columbia
Canada	Forest Investigative Site 1157	Toronto	Ontario
Canada	Forest Investigative Site 1168	Toronto	Ontario
United States	Forest Investigative Site 0980	Atlanta	Georgia
United States	Forest Investigative Site 1491	Atlanta	Georgia
United States	Forest Investigative Site 0987	Austell	Georgia
United States	Forest Investigative Site 1436	Avon	Indiana
United States	Forest Investigative Site 1333	Baltimore	Maryland
United States	Forest Investigative Site 1120	Bellingham	Washington
United States	Forest Investigative Site 1348	Bend	Oregon
United States	Forest Investigative Site 1150	Berlin	New Jersey
United States	Forest Investigative Site 1162	Birmingham	Alabama
United States	Forest Investigative Site 1154	Brandon	Florida
United States	Forest Investigative Site 1368	Bronx	New York
United States	Forest Investigative Site 2062	Bronxville	New York
United States	Forest Investigative Site 1147	Brooklyn	New York
United States	Forest Investigative Site 1483	Buena Park	California
United States	Forest Investigative Site 1134	Canton	Ohio
United States	Forest Investigative Site 2072	Charleston	South Carolina
United States	Forest Investigative Site 1334	Charlotte	North Carolina
United States	Forest Investigative Site 2081	Charlotte	North Carolina
United States	Forest Investigative Site 1339	Cherry Hill	New Jersey
United States	Forest Investigative Site 2007	Cincinnati	Ohio
United States	Forest Investigative Site 1152	Clearwater	Florida
United States	Forest Investigative Site 1434	Cleveland	Ohio
United States	Forest Investigative Site 0959	Columbus	Ohio
United States	Forest Investigative Site 1433	Columbus	Ohio
United States	Forest Investigative Site 1505	Columbus	Ohio
United States	Forest Investigative Site 1532	Columbus	Georgia
United States	Forest Investigative Site 1514	Coral Gables	Florida
United States	Forest Investigative Site 2085	Crescent Springs	Kentucky
United States	Forest Investigative Site 1520	Crestview Hills	Kentucky
United States	Forest Investigative Site 1155	Dallas	Texas
United States	Forest Investigative Site 1328	Dallas	Texas
United States	Forest Investigative Site 1435	Dayton	Ohio
United States	Forest Investigative Site 0670	DeLand	Florida
United States	Forest Investigative Site 1516	Edgewater	Florida
United States	Forest Investigative Site 1332	El Paso	Texas
United States	Forest Investigative Site 1515	Elizabeth	New Jersey
United States	Forest Investigative Site 1421	Fall River	Massachusetts
United States	Forest Investigative Site 1100	Florissant	Missouri
United States	Forest Investigative Site 1350	Foothill Ranch	California
United States	Forest Investigative Site 2037	Fort Collins	Colorado
United States	Forest Investigative Site 0990	Fort Lauderdale	Florida
United States	Forest Investigative Site 1509	Fresno	California
United States	Forest Investigative Site 2065	Fullerton	California
United States	Forest Investigative Site 1104	Hartford	Connecticut
United States	Forest Investigative Site 1504	Hershey	Pennsylvania
United States	Forest Investigative Site 1513	Hialeah	Florida
United States	Forest Investigative Site 1366	HighPoint	North Carolina
United States	Forest Investigative Site 1337	Houston	Texas
United States	Forest Investigative Site 1502	Huntington Park	California
United States	Forest Investigative Site 2024	Lafayette	Louisiana
United States	Forest Investigative Site 1088	Lakewood	California
United States	Forest Investigative Site 0539	Lexington	Kentucky
United States	Forest Investigative Site 1534	Long Beach	California
United States	Forest Investigative Site 2209	Los Angeles	California
United States	Forest Investigative Site 1336	Louisville	Kentucky
United States	Forest Investigative Site 1478	Louisville	Kentucky
United States	Forest Investigative Site 1420	Miami	Florida
United States	Forest Investigative Site 1432	Miami	Florida
United States	Forest Investigative Site 2041	Minneapolis	Minnesota
United States	Forest Investigative Site 1484	Miramar	Florida
United States	Forest Investigative Site 1127	Mobile	Alabama
United States	Forest Investigative Site 0962	Nashville	Tennessee
United States	Forest Investigative Site 1151	New Hyde Park	New York
United States	Forest Investigative Site 1114	New York	New York
United States	Forest Investigative Site 1163	New York	New York
United States	Forest Investigative Site 1346	Newark	Delaware
United States	Forest Investigative Site 1481	Newburgh	New York
United States	Forest Investigative Site 1340	Ocala	Florida
United States	Forest Investigative Site 1394	Ocean	New Jersey
United States	Forest Investigative Site 1122	Orange	California
United States	Forest Investigative Site 1508	Palm Springs	California
United States	Forest Investigative Site 1367	Papillion	Nebraska
United States	Forest Investigative Site 1488	Pembroke Pines	Florida
United States	Forest Investigative Site 0974	Pensacola	Florida
United States	Forest Investigative Site 1351	Plymouth	Minnesota
United States	Forest Investigative Site 1397	Port Charlotte	Florida
United States	Forest Investigative Site 1383	Port Orange	Florida
United States	Forest Investigative Site 1365	Rapid City	South Dakota
United States	Forest Investigative Site 2051	River Forest	Illinois
United States	Forest Investigative Site 2064	Riverside	California
United States	Forest Investigative Site 0479	Rochester	New York
United States	Forest Investigative Site 1533	Sacramento	California
United States	Forest Investigative Site 1384	San Antonio	Texas
United States	Forest Investigative Site 1396	San Antonio	Texas
United States	Forest Investigative Site 1439	San Diego	California
United States	Forest Investigative Site 1503	San Diego	California
United States	Forest Investigative Site 2009	San Diego	California
United States	Forest Investigative Site 1347	San Jose	California
United States	Forest Investigative Site 1475	Scottsdale	Arizona
United States	Forest Investigative Site 0989	Skokie	Illinois
United States	Forest Investigative Site 1330	South Burlington	Vermont
United States	Forest Investigative Site 0900	Spartanburg	South Carolina
United States	Forest Investigative Site 1344	Spring Valley	California
United States	Forest Investigative Site 2079	St. Charles	Missouri
United States	Forest Investigative Site 1329	St. Louis	Missouri
United States	Forest Investigative Site 1335	St. Louis	Missouri
United States	Forest Investigative Site 1343	St. Louis	Missouri
United States	Forest Investigative Site 1369	St. Louis	Missouri
United States	Forest Investigative Site 1482	Stamford	Connecticut
United States	Forest Investigative Site 1382	Statesville	North Carolina
United States	Forest Investigative Site 1342	Stevensville	Michigan
United States	Forest Investigative Site 1531	Tacoma	Washington
United States	Forest Investigative Site 2082	Tamarac	Florida
United States	Forest Investigative Site 2047	Tampa	Florida
United States	Forest Investigative Site 1338	Tempe	Arizona
United States	Forest Investigative Site 1349	Tucson	Arizona
United States	Forest Investigative Site 1395	Valrico	Florida
United States	Forest Investigative Site 2039	Walnut Creek	California
United States	Forest Investigative Site 1327	Wheat Ridge	Colorado
United States	Forest Investigative Site 1438	Ypsilanti	Michigan

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 (Trough) Forced Expiratory Volume in One Second (FEV1)	Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.	From baseline to 52 weeks	No
Secondary	Change From Baseline in Peak FEV1	Change From Baseline in Peak FEV1 in liters at Week 52.	52 weeks	No