Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)

Chronic Obstructive Pulmonary Disease Clinical Trial

— LAS-MD-38  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045161
• Other study ID #: LAS-MD-38
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2010
• Last updated: November 4, 2015
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2015
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Est. completion date: June 2011
• Est. primary completion date: June 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, 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.

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 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.
• 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
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

Locations

Country	Name	City	State
Canada	Forest Investigative Site 1177	Vancouver	British Columbia
Canada	Forest Investigative Site 0969	Windsor	Ontario
United States	Forest Investigative Site 1480	Abingdon	Virginia
United States	Forest Investigative Site 1486	Albuquerque	New Mexico
United States	Forest Investigative Site 1389	Amarillo	Texas
United States	Forest Investigative Site 1479	Anderson	Indiana
United States	Forest Investigative Site 1440	Arlington	Texas
United States	Forest Investigative Site 1386	Atlanta	Georgia
United States	Forest Investigative Site 1494	Austin	Texas
United States	Forest Investigative Site 1412	Baltimore	Maryland
United States	Forest Investigative Site 1354	Bellevue	Nebraska
United States	Forest Investigative Site 1367	Bellevue	Nebraska
United States	Forest Investigative Site 1419	Birmingham	Alabama
United States	Forest Investigative Site 1493	Birmingham	Alabama
United States	Forest Investigative Site 2033	Bowling Green	Kentucky
United States	Forest Investigative Site 1442	Brockton	Massachusetts
United States	Forest Investigative Site 1411	Calhoun	Georgia
United States	Forest Investigative Site 1392	Charlotte	North Carolina
United States	Forest Investigative Site 1405	Chelsea	Michigan
United States	Forest Investigative Site 1136	Cincinnati	Ohio
United States	Forest Investigative Site 1371	Cincinnati	Ohio
United States	Forest Investigative Site 1364	Clearwater	Florida
United States	Forest Investigative Site 0679	Coeur d' Alene	Idaho
United States	Forest Investigative Site 1377	Collegeville	Pennsylvania
United States	Forest Investigative Site 1144	Columbia	South Carolina
United States	Forest Investigative Site 1361	Columbus	Ohio
United States	Forest Investigative Site 1433	Columbus	Ohio
United States	Forest Investigative Site 1517	Easley	South Carolina
United States	Forest Investigative Site 1516	Edgewater	Florida
United States	Forest Investigative Site 1128	Edina	Minnesota
United States	Forest Investigative Site 1385	Elk Grove Village	Illinois
United States	Forest Investigative Site 1423	Erie	Pennsylvania
United States	Forest Investigative Site 2022	Evansville	Indiana
United States	Forest Investigative Site 1421	Fall River	Massachusetts
United States	Forest Investigative Site 1526	Fayetteville	Tennessee
United States	Forest Investigative Site 1428	Feasterville	Pennsylvania
United States	Forest Investigative Site 1476	Fremont	Nebraska
United States	Forest Investigative Site 1527	Fridley	Minnesota
United States	Forest Investigative Site 2065	Fullerton	California
United States	Forest Investigative Site 1380	Golden	Colorado
United States	Forest Investigative Site 1506	Grenville	South Carolina
United States	Forest Investigative Site 1090	Hazard	Kentucky
United States	Forest Investigative Site 1359	Henderson	Nevada
United States	Forest Investigative Site 1366	High Point	North Carolina
United States	Forest Investigative Site 1403	Hollywood	Florida
United States	Forest Investigative Site 1485	Homestead	Florida
United States	Forest Investigative Site 1375	Houston	Texas
United States	Forest Investigative Site 1381	Houston	Texas
United States	Forest Investigative Site 1401	Houston	Texas
United States	Forest Investigative Site 1444	Houston	Texas
United States	Forest Investigative Site 1357	Hurst	Texas
United States	Forest Investigative Site 1441	Indianapolis	Indiana
United States	Forest Investigative Site 1406	Iowa City	Iowa
United States	Forest Investigative Site 1445	Johnston	Rhode Island
United States	Forest Investigative Site 1356	Knoxville	Tennessee
United States	Forest Investigative Site 1417	Knoxville	Tennessee
United States	Forest Investigative Site 1489	Larchmont	New York
United States	Forest Investigative Site 1355	Las Vegas	Nevada
United States	Forest Investigative Site 1528	Lawrenceville	Georgia
United States	Forest Investigative Site 1477	Lincoln	Rhode Island
United States	Forest Investigative Site 0889	Livonia	Michigan
United States	Forest Investigative Site 1402	Lynchburg	Virginia
United States	Forest Investigative Site 2018	Medford	Oregon
United States	Forest Investigative Site 2043	Medford	Oregon
United States	Forest Investigative Site 1352	Miami	Florida
United States	Forest Investigative Site 1124	Minneapolis	Minnesota
United States	Forest Investigative Site 1400	Missoula	Montana
United States	Forest Investigative Site 1413	Muscle Shoals	Alabama
United States	Forest Investigative Site 1391	Naples	Florida
United States	Forest Investigative Site 1451	National City	California
United States	Forest Investigative Site 1430	New Orleans	Louisiana
United States	Forest Investigative Site 1446	New Orleans	Louisiana
United States	Forest Investigative Site 1425	New York	New York
United States	Forest Investigative Site 1404	Norfolk	Virginia
United States	Forest Investigative Site 1029	North Dartmouth	Massachusetts
United States	Forest Investigative Site 1518	North East	Maryland
United States	Forest Investigative Site 1373	North Syracuse	New York
United States	Forest Investigative Site 1409	O'Fallon	Illinois
United States	Forest Investigative Site 1362	Oklahoma City	Oklahoma
United States	Forest Investigative Site 1363	Omaha	Nebraska
United States	Forest Investigative Site 1390	Omaha	Nebraska
United States	Forest Investigative Site 1422	Omaha	Nebraska
United States	Forest Investigative Site 1388	Paramount	California
United States	Forest Investigative Site 1353	Pell City	Alabama
United States	Forest Investigative Site 1443	Philadelphia	Pennsylvania
United States	Forest Investigative Site 1379	Phoenix	Arizona
United States	Forest Investigative Site 1510	Pittsburgh	Pennsylvania
United States	Forest Investigative Site 1426	Plano	Texas
United States	Forest Investigative Site 1376	Port Orange	Florida
United States	Forest Investigative Site 1447	Pueblo	Colorado
United States	Forest Investigative Site 1358	Richmond	Virginia
United States	Forest Investigative Site 1118	Rochester	Minnesota
United States	Forest Investigative Site 1424	Rolling Hill Estates	California
United States	Forest Investigative Site 1427	Sacramento	California
United States	Forest Investigative Site 1418	San Diego	California
United States	Forest Investigative Site 2009	San Diego	California
United States	Forest Investigative Site 1149	South Bend	Indiana
United States	Forest Investigative Site 1372	South Miami	Florida
United States	Forest Investigative Site 1399	St. Louis	Missouri
United States	Forest Investigative Site 1360	Sunset	Louisiana
United States	Forest Investigative Site 0988	Tacoma	Washington
United States	Forest Investigative Site 1449	Tipton	Pennsylvania
United States	Forest Investigative Site 1530	Toledo	Ohio
United States	Forest Investigative Site 1410	Tomball	Texas
United States	Forest Investigative Site 1080	Topeka	Kansas
United States	Forest Investigative Site 1374	Torrance	California
United States	Forest Investigative Site 1407	Trinity	Florida
United States	Forest Investigative Site 1487	Troy	Michigan
United States	Forest Investigative Site 1450	Union	South Carolina
United States	Forest Investigative Site 1331	Vista	California
United States	Forest Investigative Site 1185	Winter Park	Florida
United States	Forest Investigative Site 1393	Zanesville	Ohio

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	Part A: Morning Predose (Trough) 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 (Week 0) to Week 12	No
Primary	Part B: Morning Predose (Trough) FEV1	Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)	Change from baseline (Week 0) to 52 Weeks	No
Secondary	Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)	Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)	Change from baseline (Week 0) to Week 12	No
Secondary	Part B: Peak FEV1	Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)	Change from baseline (Week 0) to 52 Weeks	No