Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970268
• Other study ID #: LAS-MD-36
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2009
• Last updated: August 14, 2012
• Start date: January 2010

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 extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Completion of a lead-in study (NCT00891462)

Exclusion Criteria:

• Use or anticipated use of any medication prohibited in this study

• Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings

• The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)

• QTcB of >500 msec on both the pre-dose and post-dose ECG

• Women who are pregnant, intend to become pregnant, or are breast-feeding

• A life expectancy of less than 1 year

• Noncompliance with IP dosing and/or attending clinic visits during the lead-in study

• Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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 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 2200	Niagara Falls	Ontario
Canada	Forest Investigative Site 1168	Toronto	Ontario
Canada	Forest Investigative Site 1171	Toronto	Ontario
Canada	Forest Investigative Site 2203	Toronto	Ontario
Canada	Forest Investigative Site 1177	Vancouver	British Columbia
United States	Forest Investigative Site 1130	Asheville	North Carolina
United States	Forest Investigative Site 1183	Atlanta	Georgia
United States	Forest Investigative Site 0987	Austell	Georgia
United States	Forest Investigative Site 1150	Berlin	New Jersey
United States	Forest Investigative Site 1126	Bethlehem	Pennsylvania
United States	Forest Investigative Site 2040	Biddeford	Maine
United States	Forest Investigative Site 1162	Birmingham	Alabama
United States	Forest Investigative Site 1101	Blue Ridge	Georgia
United States	Forest Investigative Site 1154	Brandon	Florida
United States	Forest Investigative Site 1147	Brooklyn	New York
United States	Forest Investigative Site 2067	Butte	Montana
United States	Forest Investigative Site 1134	Canton	Ohio
United States	Forest Investigative Site 1181	Centerville	Ohio
United States	Forest Investigative Site 2072	Charleston	South Carolina
United States	Forest Investigative Site 1136	Cincinnati	Ohio
United States	Forest Investigative Site 2007	Cincinnati	Ohio
United States	Forest Investigative Site 2028	Cincinnati	Ohio
United States	Forest Investigative Site 1152	Clearwater	Florida
United States	Forest Investigative Site 1137	Colorado Springs	Colorado
United States	Forest Investigative Site 0959	Columbus	Ohio
United States	Forest Investigative Site 2006	Columbus	Ohio
United States	Forest Investigative Site 2085	Crescent Springs	Kentucky
United States	Forest Investigative Site 1155	Dallas	Texas
United States	Forest Investigative Site 1180	Decatur	Georgia
United States	Forest Investigative Site 0670	DeLand	Florida
United States	Forest Investigative Site 1161	Duluth	Georgia
United States	Forest Investigative Site 1089	East Providence	Rhode Island
United States	Forest Investigative Site 1128	Edina	Minnesota
United States	Forest Investigative Site 1119	Elmira	New York
United States	Forest Investigative Site 2016	Erie	Pennsylvania
United States	Forest Investigative Site 1100	Florissant	Missouri
United States	Forest Investigative Site 0990	Fort Lauderdale	Florida
United States	Forest Investigative Site 2012	Fort Worth	Texas
United States	Forest Investigative Site 2065	Fullerton	California
United States	Forest Investigative Site 0909	Glendale	Arizona
United States	Forest Investigative Site 1078	Greenville	South Carolina
United States	Forest Investigative Site 2080	Greer	South Carolina
United States	Forest Investigative Site 1144	Johnston	Rhode Island
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 2043	Medford	Oregon
United States	Forest Investigative Site 1167	Melbourne	Florida
United States	Forest Investigative Site 1124	Minneapolis	Minnesota
United States	Forest Investigative Site 2041	Minneapolis	Minnesota
United States	Forest Investigative Site 1127	Mobile	Alabama
United States	Forest Investigative Site 1151	New Hyde Park	New York
United States	Forest Investigative Site 1141	New York	New York
United States	Forest Investigative Site 1163	New York	New York
United States	Forest Investigative Site 1122	Orange	California
United States	Forest Investigative Site 1060	Ormond Beach	Florida
United States	Forest Investigative Site 1169	Papillion	Nebraska
United States	Forest Investigative Site 0974	Pensacola	Florida
United States	Forest Investigative Site 2060	Phoenix	Arizona
United States	Forest Investigative Site 1146	Pittsburgh	Pennsylvania
United States	Forest Investigative Site 1106	Portland	Oregon
United States	Forest Investigative Site 2029	Rancho Mirage	California
United States	Forest Investigative Site 2099	Richmond	Virginia
United States	Forest Investigative Site 2051	River Forest	Illinois
United States	Forets Investigative Site 2064	Riverside	California
United States	Forest Investigative Site 0517	Sacramento	California
United States	Forest Investigative Site 1165	San Antonio	Texas
United States	Forest Investigative Site 2009	San Diego	California
United States	Forest Investigative Site 0989	Skokie	Illinois
United States	Forest Investigative Site 1149	South Bend	Indiana
United States	Forest Investigative Site 1121	Spartanburg	South Carolina
United States	Forest Investigative Site 1142	Spokane	Washington
United States	Forest Investigative Site 2079	St. Charles	Missouri
United States	Forest Investigative Site 2084	Summit	New Jersey
United States	Forest Investigative Site 0988	Tacoma	Washington
United States	Forest Investigative Site 2082	Tamarac	Florida
United States	Forest Investigative Site 2047	Tampa	Florida
United States	Forest Investigative Site 2053	Tampa	Florida
United States	Forest Investigative Site 1158	Upland	Pennsylvania
United States	Forest Investigative Site 1129	Waco	Texas
United States	Forest Investigative Site 2100	Waterbury	Connecticut
United States	Forest Investigative Site 1185	Winter Park	Florida

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 (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1	Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks	No
Secondary	Change From Baseline in Peak FEV1	Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).	52 weeks	No