Clinical trial NCT01045161: Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Chronic Bronchitis
Emphysema
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-01-08
Enrollment: 544
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Change from baseline (Week 0) to Week 12
measure: Part B: Morning Predose (Trough) FEV1
timeFrame: Change from baseline (Week 0) to 52 Weeks
Secondary outcomes:
measure: Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Change from baseline (Week 0) to Week 12
measure: Part B: Peak FEV1
timeFrame: Change from baseline (Week 0) to 52 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 1493
state: Alabama
city: Birmingham
country: United States
facility: Forest Investigative Site 1419
state: Alabama
city: Muscle Shoals
country: United States
facility: Forest Investigative Site 1413
state: Alabama
city: Pell City
country: United States
facility: Forest Investigative Site 1353
state: Alabama
city: Phoenix
country: United States
facility: Forest Investigative Site 1379
state: Arizona
city: Fullerton
country: United States
facility: Forest Investigative Site 2065
state: California
city: National City
country: United States
facility: Forest Investigative Site 1451
state: California
city: Paramount
country: United States
facility: Forest Investigative Site 1388
state: California
city: Rolling Hill Estates
country: United States
facility: Forest Investigative Site 1424
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 1427
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 1418
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 2009
state: California
city: Torrance
country: United States
facility: Forest Investigative Site 1374
state: California
city: Vista
country: United States
facility: Forest Investigative Site 1331
state: California
city: Golden
country: United States
facility: Forest Investigative Site 1380
state: Colorado
city: Pueblo
country: United States
facility: Forest Investigative Site 1447
state: Colorado
city: Clearwater
country: United States
facility: Forest Investigative Site 1364
state: Florida
city: Edgewater
country: United States
facility: Forest Investigative Site 1516
state: Florida
city: Hollywood
country: United States
facility: Forest Investigative Site 1403
state: Florida
city: Homestead
country: United States
facility: Forest Investigative Site 1485
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 1352
state: Florida
city: Naples
country: United States
facility: Forest Investigative Site 1391
state: Florida
city: Port Orange
country: United States
facility: Forest Investigative Site 1376
state: Florida
city: South Miami
country: United States
facility: Forest Investigative Site 1372
state: Florida
city: Trinity
country: United States
facility: Forest Investigative Site 1407
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 1185
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 1386
state: Georgia
city: Calhoun
country: United States
facility: Forest Investigative Site 1411
state: Georgia
city: Lawrenceville
country: United States
facility: Forest Investigative Site 1528
state: Georgia
city: Coeur d' Alene
country: United States
facility: Forest Investigative Site 0679
state: Idaho
city: Elk Grove Village
country: United States
facility: Forest Investigative Site 1385
state: Illinois
city: O'Fallon
country: United States
facility: Forest Investigative Site 1409
state: Illinois
city: Anderson
country: United States
facility: Forest Investigative Site 1479
state: Indiana
city: Evansville
country: United States
facility: Forest Investigative Site 2022
state: Indiana
city: Indianapolis
country: United States
facility: Forest Investigative Site 1441
state: Indiana
city: South Bend
country: United States
facility: Forest Investigative Site 1149
state: Indiana
city: Iowa City
country: United States
facility: Forest Investigative Site 1406
state: Iowa
city: Topeka
country: United States
facility: Forest Investigative Site 1080
state: Kansas
city: Bowling Green
country: United States
facility: Forest Investigative Site 2033
state: Kentucky
city: Hazard
country: United States
facility: Forest Investigative Site 1090
state: Kentucky
city: New Orleans
country: United States
facility: Forest Investigative Site 1430
state: Louisiana
city: New Orleans
country: United States
facility: Forest Investigative Site 1446
state: Louisiana
city: Sunset
country: United States
facility: Forest Investigative Site 1360
state: Louisiana
city: Baltimore
country: United States
facility: Forest Investigative Site 1412
state: Maryland
city: North East
country: United States
facility: Forest Investigative Site 1518
state: Maryland
city: Brockton
country: United States
facility: Forest Investigative Site 1442
state: Massachusetts
city: Fall River
country: United States
facility: Forest Investigative Site 1421
state: Massachusetts
city: North Dartmouth
country: United States
facility: Forest Investigative Site 1029
state: Massachusetts
city: Chelsea
country: United States
facility: Forest Investigative Site 1405
state: Michigan
city: Livonia
country: United States
facility: Forest Investigative Site 0889
state: Michigan
city: Troy
country: United States
facility: Forest Investigative Site 1487
state: Michigan
city: Edina
country: United States
facility: Forest Investigative Site 1128
state: Minnesota
city: Fridley
country: United States
facility: Forest Investigative Site 1527
state: Minnesota
city: Minneapolis
country: United States
facility: Forest Investigative Site 1124
state: Minnesota
city: Rochester
country: United States
facility: Forest Investigative Site 1118
state: Minnesota
city: St. Louis
country: United States
facility: Forest Investigative Site 1399
state: Missouri
city: Missoula
country: United States
facility: Forest Investigative Site 1400
state: Montana
city: Bellevue
country: United States
facility: Forest Investigative Site 1354
state: Nebraska
city: Bellevue
country: United States
facility: Forest Investigative Site 1367
state: Nebraska
city: Fremont
country: United States
facility: Forest Investigative Site 1476
state: Nebraska
city: Omaha
country: United States
facility: Forest Investigative Site 1363
state: Nebraska
city: Omaha
country: United States
facility: Forest Investigative Site 1390
state: Nebraska
city: Omaha
country: United States
facility: Forest Investigative Site 1422
state: Nebraska
city: Henderson
country: United States
facility: Forest Investigative Site 1359
state: Nevada
city: Las Vegas
country: United States
facility: Forest Investigative Site 1355
state: Nevada
city: Albuquerque
country: United States
facility: Forest Investigative Site 1486
state: New Mexico
city: Larchmont
country: United States
facility: Forest Investigative Site 1489
state: New York
city: New York
country: United States
facility: Forest Investigative Site 1425
state: New York
city: North Syracuse
country: United States
facility: Forest Investigative Site 1373
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 1392
state: North Carolina
city: High Point
country: United States
facility: Forest Investigative Site 1366
state: North Carolina
city: Cincinnati
country: United States
facility: Forest Investigative Site 1136
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 1371
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 1361
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 1433
state: Ohio
city: Toledo
country: United States
facility: Forest Investigative Site 1530
state: Ohio
city: Zanesville
country: United States
facility: Forest Investigative Site 1393
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 1362
state: Oklahoma
city: Medford
country: United States
facility: Forest Investigative Site 2018
state: Oregon
city: Medford
country: United States
facility: Forest Investigative Site 2043
state: Oregon
city: Collegeville
country: United States
facility: Forest Investigative Site 1377
state: Pennsylvania
city: Erie
country: United States
facility: Forest Investigative Site 1423
state: Pennsylvania
city: Feasterville
country: United States
facility: Forest Investigative Site 1428
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 1443
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 1510
state: Pennsylvania
city: Tipton
country: United States
facility: Forest Investigative Site 1449
state: Pennsylvania
city: Johnston
country: United States
facility: Forest Investigative Site 1445
state: Rhode Island
city: Lincoln
country: United States
facility: Forest Investigative Site 1477
state: Rhode Island
city: Columbia
country: United States
facility: Forest Investigative Site 1144
state: South Carolina
city: Easley
country: United States
facility: Forest Investigative Site 1517
state: South Carolina
city: Grenville
country: United States
facility: Forest Investigative Site 1506
state: South Carolina
city: Union
country: United States
facility: Forest Investigative Site 1450
state: South Carolina
city: Fayetteville
country: United States
facility: Forest Investigative Site 1526
state: Tennessee
city: Knoxville
country: United States
facility: Forest Investigative Site 1356
state: Tennessee
city: Knoxville
country: United States
facility: Forest Investigative Site 1417
state: Tennessee
city: Amarillo
country: United States
facility: Forest Investigative Site 1389
state: Texas
city: Arlington
country: United States
facility: Forest Investigative Site 1440
state: Texas
city: Austin
country: United States
facility: Forest Investigative Site 1494
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 1375
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 1444
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 1401
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 1381
state: Texas
city: Hurst
country: United States
facility: Forest Investigative Site 1357
state: Texas
city: Plano
country: United States
facility: Forest Investigative Site 1426
state: Texas
city: Tomball
country: United States
facility: Forest Investigative Site 1410
state: Texas
city: Abingdon
country: United States
facility: Forest Investigative Site 1480
state: Virginia
city: Lynchburg
country: United States
facility: Forest Investigative Site 1402
state: Virginia
city: Norfolk
country: United States
facility: Forest Investigative Site 1404
state: Virginia
city: Richmond
country: United States
facility: Forest Investigative Site 1358
state: Virginia
city: Tacoma
country: United States
facility: Forest Investigative Site 0988
state: Washington
city: Vancouver
country: Canada
facility: Forest Investigative Site 1177
state: British Columbia
city: Windsor
country: Canada
facility: Forest Investigative Site 0969
state: Ontario
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, Ph. D.
role: STUDY_DIRECTOR
References:
citation: Rennard SI, Scanlon PD, Ferguson GT, Rekeda L, Maurer BT, Garcia Gil E, Caracta CF. ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients. Clin Drug Investig. 2013 Dec;33(12):893-904. doi: 10.1007/s40261-013-0138-1.