Clinical trial NCT01044459: Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (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
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: 2010-01-07
Enrollment: 605
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 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.


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, 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.

Primary outcomes:
measure: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
timeFrame: From baseline to 52 weeks
Secondary outcomes:
measure: Change From Baseline in Peak FEV1
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 1162
state: Alabama
city: Mobile
country: United States
facility: Forest Investigative Site 1127
state: Alabama
city: Scottsdale
country: United States
facility: Forest Investigative Site 1475
state: Arizona
city: Tempe
country: United States
facility: Forest Investigative Site 1338
state: Arizona
city: Tucson
country: United States
facility: Forest Investigative Site 1349
state: Arizona
city: Buena Park
country: United States
facility: Forest Investigative Site 1483
state: California
city: Foothill Ranch
country: United States
facility: Forest Investigative Site 1350
state: California
city: Fresno
country: United States
facility: Forest Investigative Site 1509
state: California
city: Fullerton
country: United States
facility: Forest Investigative Site 2065
state: California
city: Huntington Park
country: United States
facility: Forest Investigative Site 1502
state: California
city: Lakewood
country: United States
facility: Forest Investigative Site 1088
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site 1534
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 2209
state: California
city: Orange
country: United States
facility: Forest Investigative Site 1122
state: California
city: Palm Springs
country: United States
facility: Forest Investigative Site 1508
state: California
city: Riverside
country: United States
facility: Forest Investigative Site 2064
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 1533
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 2009
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 1439
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 1503
state: California
city: San Jose
country: United States
facility: Forest Investigative Site 1347
state: California
city: Spring Valley
country: United States
facility: Forest Investigative Site 1344
state: California
city: Walnut Creek
country: United States
facility: Forest Investigative Site 2039
state: California
city: Fort Collins
country: United States
facility: Forest Investigative Site 2037
state: Colorado
city: Wheat Ridge
country: United States
facility: Forest Investigative Site 1327
state: Colorado
city: Hartford
country: United States
facility: Forest Investigative Site 1104
state: Connecticut
city: Stamford
country: United States
facility: Forest Investigative Site 1482
state: Connecticut
city: Newark
country: United States
facility: Forest Investigative Site 1346
state: Delaware
city: Brandon
country: United States
facility: Forest Investigative Site 1154
state: Florida
city: Clearwater
country: United States
facility: Forest Investigative Site 1152
state: Florida
city: Coral Gables
country: United States
facility: Forest Investigative Site 1514
state: Florida
city: DeLand
country: United States
facility: Forest Investigative Site 0670
state: Florida
city: Edgewater
country: United States
facility: Forest Investigative Site 1516
state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site 0990
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site 1513
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 1420
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 1432
state: Florida
city: Miramar
country: United States
facility: Forest Investigative Site 1484
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site 1340
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 1488
state: Florida
city: Pensacola
country: United States
facility: Forest Investigative Site 0974
state: Florida
city: Port Charlotte
country: United States
facility: Forest Investigative Site 1397
state: Florida
city: Port Orange
country: United States
facility: Forest Investigative Site 1383
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site 2082
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 2047
state: Florida
city: Valrico
country: United States
facility: Forest Investigative Site 1395
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 0980
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 1491
state: Georgia
city: Austell
country: United States
facility: Forest Investigative Site 0987
state: Georgia
city: Columbus
country: United States
facility: Forest Investigative Site 1532
state: Georgia
city: River Forest
country: United States
facility: Forest Investigative Site 2051
state: Illinois
city: Skokie
country: United States
facility: Forest Investigative Site 0989
state: Illinois
city: Avon
country: United States
facility: Forest Investigative Site 1436
state: Indiana
city: Crescent Springs
country: United States
facility: Forest Investigative Site 2085
state: Kentucky
city: Crestview Hills
country: United States
facility: Forest Investigative Site 1520
state: Kentucky
city: Lexington
country: United States
facility: Forest Investigative Site 0539
state: Kentucky
city: Louisville
country: United States
facility: Forest Investigative Site 1336
state: Kentucky
city: Louisville
country: United States
facility: Forest Investigative Site 1478
state: Kentucky
city: Lafayette
country: United States
facility: Forest Investigative Site 2024
state: Louisiana
city: Baltimore
country: United States
facility: Forest Investigative Site 1333
state: Maryland
city: Fall River
country: United States
facility: Forest Investigative Site 1421
state: Massachusetts
city: Stevensville
country: United States
facility: Forest Investigative Site 1342
state: Michigan
city: Ypsilanti
country: United States
facility: Forest Investigative Site 1438
state: Michigan
city: Minneapolis
country: United States
facility: Forest Investigative Site 2041
state: Minnesota
city: Plymouth
country: United States
facility: Forest Investigative Site 1351
state: Minnesota
city: Florissant
country: United States
facility: Forest Investigative Site 1100
state: Missouri
city: St. Charles
country: United States
facility: Forest Investigative Site 2079
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 1343
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 1329
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 1369
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 1335
state: Missouri
city: Papillion
country: United States
facility: Forest Investigative Site 1367
state: Nebraska
city: Berlin
country: United States
facility: Forest Investigative Site 1150
state: New Jersey
city: Cherry Hill
country: United States
facility: Forest Investigative Site 1339
state: New Jersey
city: Elizabeth
country: United States
facility: Forest Investigative Site 1515
state: New Jersey
city: Ocean
country: United States
facility: Forest Investigative Site 1394
state: New Jersey
city: Bronxville
country: United States
facility: Forest Investigative Site 2062
state: New York
city: Bronx
country: United States
facility: Forest Investigative Site 1368
state: New York
city: Brooklyn
country: United States
facility: Forest Investigative Site 1147
state: New York
city: New Hyde Park
country: United States
facility: Forest Investigative Site 1151
state: New York
city: New York
country: United States
facility: Forest Investigative Site 1114
state: New York
city: New York
country: United States
facility: Forest Investigative Site 1163
state: New York
city: Newburgh
country: United States
facility: Forest Investigative Site 1481
state: New York
city: Rochester
country: United States
facility: Forest Investigative Site 0479
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 2081
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 1334
state: North Carolina
city: HighPoint
country: United States
facility: Forest Investigative Site 1366
state: North Carolina
city: Statesville
country: United States
facility: Forest Investigative Site 1382
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site 1134
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 2007
state: Ohio
city: Cleveland
country: United States
facility: Forest Investigative Site 1434
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 1433
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 0959
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 1505
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site 1435
state: Ohio
city: Bend
country: United States
facility: Forest Investigative Site 1348
state: Oregon
city: Hershey
country: United States
facility: Forest Investigative Site 1504
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site 2072
state: South Carolina
city: Spartanburg
country: United States
facility: Forest Investigative Site 0900
state: South Carolina
city: Rapid City
country: United States
facility: Forest Investigative Site 1365
state: South Dakota
city: Nashville
country: United States
facility: Forest Investigative Site 0962
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 1155
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 1328
state: Texas
city: El Paso
country: United States
facility: Forest Investigative Site 1332
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 1337
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 1396
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 1384
state: Texas
city: South Burlington
country: United States
facility: Forest Investigative Site 1330
state: Vermont
city: Bellingham
country: United States
facility: Forest Investigative Site 1120
state: Washington
city: Tacoma
country: United States
facility: Forest Investigative Site 1531
state: Washington
city: Kelowna
country: Canada
facility: Forest Investigative Site 2201
state: British Columbia
city: Toronto
country: Canada
facility: Forest Investigative Site 1157
state: Ontario
city: Toronto
country: Canada
facility: Forest Investigative Site 1168
state: Ontario
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References: