Clinical trial NCT01437540: Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official title: A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Chronic Obstructive Pulmonary Disease
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: 2011-09-21
Enrollment: 590
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 assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
* A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria:

* Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
* Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
* Patients with any clinically significant respiratory conditions other than COPD
* Clinical history that suggests that the patient has asthma as opposed to COPD
* Chronic use of oxygen therapy ≥ 15 hours/day
* Patients with clinically significant cardiovascular conditions
* Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
* Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
* Current diagnosis of cancer other than basal or squamous cell skin cancer

Primary outcomes:
measure: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: Up to study Week 56 ± 3 days
Secondary outcomes:
measure: Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study
timeFrame: Up to study Week 52
measure: Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
timeFrame: Up to study Week 56 ± 3 days
measure: Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
timeFrame: Up to study Week 56 ± 3 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 1162
state: Alabama
city: Birmingham
country: United States
facility: Forest Investigative Site 1493
state: Alabama
city: Birmingham
country: United States
facility: Forest Investigative Site 1620
state: Alabama
city: Mobile
country: United States
facility: Forest Investigative Site 1127
state: Alabama
city: Chandler
country: United States
facility: Forest Investigative Site 1613
state: Arizona
city: Peoria
country: United States
facility: Forest Investigative Site 1623
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 1582
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 1379
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 1581
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 1571
state: Arizona
city: Fort Smith
country: United States
facility: Forest Investigative Site 1596
state: Arkansas
city: Encinitas
country: United States
facility: Forest Investigative Site 1547
state: California
city: Lakewood
country: United States
facility: Forest Investigative Site 1088
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 1624
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 1927
state: California
city: Paramount
country: United States
facility: Forest Investigative Site 1388
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 1503
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: Walnut Creek
country: United States
facility: Forest Investigative Site 2039
state: California
city: Boulder
country: United States
facility: Forest Investigative Site 1597
state: Colorado
city: Colorado Springs
country: United States
facility: Forest Investigative Site 1137
state: Colorado
city: Denver
country: United States
facility: Forest Investigative Site 0892
state: Colorado
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: Wheat Ridge
country: United States
facility: Forest Investigative Site 2045
state: Colorado
city: Norwalk
country: United States
facility: Forest Investigative Site 1589
state: Connecticut
city: Stamford
country: United States
facility: Forest Investigative Site 1598
state: Connecticut
city: Brandon
country: United States
facility: Forest Investigative Site 1154
state: Florida
city: Brandon
country: United States
facility: Forest Investigative Site 1944
state: Florida
city: Clearwater
country: United States
facility: Forest Investigative Site 1152
state: Florida
city: Debary
country: United States
facility: Forest Investigative Site 1617
state: Florida
city: Debary
country: United States
facility: Forest Investigative Site 1959
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: Orlando
country: United States
facility: Forest Investigative Site 1556
state: Florida
city: Ormond Beach
country: United States
facility: Forest Investigative Site 1542
state: Florida
city: Pensacola
country: United States
facility: Forest Investigative Site 0974
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 2047
state: Florida
city: Venice
country: United States
facility: Forest Investigative Site 1565
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 1851
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 0980
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 1567
state: Georgia
city: Lawrenceville
country: United States
facility: Forest Investigative Site 1607
state: Georgia
city: O'Fallon
country: United States
facility: Forest Investigative Site 1409
state: Illinois
city: River Forest
country: United States
facility: Forest Investigative Site 2051
state: Illinois
city: Springfield
country: United States
facility: Forest Investigative Site 1604
state: Illinois
city: Evansville
country: United States
facility: Forest Investigative Site 1576
state: Indiana
city: Council Bluffs
country: United States
facility: Forest Investigative Site 1549
state: Iowa
city: Bowling Green
country: United States
facility: Forest Investigative Site 2033
state: Kentucky
city: Crescent Springs
country: United States
facility: Forest Investigative Site 2085
state: Kentucky
city: Louisville
country: United States
facility: Forest Investigative Site 1336
state: Kentucky
city: Lafayette
country: United States
facility: Forest Investigative Site 2024
state: Louisiana
city: New Orleans
country: United States
facility: Forest Investigative Site 1430
state: Louisiana
city: Sunset
country: United States
facility: Forest Investigative Site 1360
state: Louisiana
city: Auburn
country: United States
facility: Forest Investigative Site 1566
state: Maine
city: Baltimore
country: United States
facility: Forest Investigative Site 1333
state: Maryland
city: Columbia
country: United States
facility: Forest Investigative Site 1622
state: Maryland
city: Towson
country: United States
facility: Forest Investigative Site 1590
state: Maryland
city: Fall River
country: United States
facility: Forest Investigative Site 1570
state: Massachusetts
city: Haverhill
country: United States
facility: Forest Investigative Site 1546
state: Massachusetts
city: North Dartmouth
country: United States
facility: Forest Investigative Site 1029
state: Massachusetts
city: Worcestor
country: United States
facility: Forest Investigative Site 1595
state: Massachusetts
city: Traverse City
country: United States
facility: Forest Investigative Site 1605
state: Michigan
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: Plymouth
country: United States
facility: Forest Investigative Site 1619
state: Minnesota
city: Chesterfield
country: United States
facility: Forest Investigative Site 1587
state: Missouri
city: Jefferson City
country: United States
facility: Forest Investigative Site 1572
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 1399
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 1599
state: Missouri
city: Bozeman
country: United States
facility: Forest Investigative Site 1831
state: Montana
city: Missoula
country: United States
facility: Forest Investigative Site 1400
state: Montana
city: Bellevue
country: United States
facility: Forest Investigative Site 1609
state: Nebraska
city: Lincoln
country: United States
facility: Forest Investigative Site 1616
state: Nebraska
city: Omaha
country: United States
facility: Forest Investigative Site 1615
state: Nebraska
city: Las Vegas
country: United States
facility: Forest Investigative Site 1562
state: Nevada
city: Rochester
country: United States
facility: Forest Investigative Site 1610
state: New Hampshire
city: Brick
country: United States
facility: Forest Investigative Site 1558
state: New Jersey
city: Cherry Hill
country: United States
facility: Forest Investigative Site 1559
state: New Jersey
city: Ocean
country: United States
facility: Forest Investigative Site 1394
state: New Jersey
city: Summit
country: United States
facility: Forest Investigative Site 2084
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site 0972
state: New York
city: New York
country: United States
facility: Forest Investigative Site 1163
state: New York
city: New York
country: United States
facility: Forest Investigative Site 1425
state: New York
city: Newburgh
country: United States
facility: Forest Investigative Site 1554
state: New York
city: Syracuse
country: United States
facility: Forest Investigative Site 1563
state: New York
city: Raleigh
country: United States
facility: Forest Investigative Site 1557
state: North Carolina
city: Shelby
country: United States
facility: Forest Investigative Site 1588
state: North Carolina
city: Wilmington
country: United States
facility: Forest Investigative Site 1553
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site 1550
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site 1134
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 1594
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 2028
state: Ohio
city: Marion
country: United States
facility: Forest Investigative Site 1541
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: Ashland
country: United States
facility: Forest Investigative Site 1612
state: Oregon
city: Corvallis
country: United States
facility: Forest Investigative Site 1575
state: Oregon
city: Eugene
country: United States
facility: Forest Investigative Site 1081
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site 1580
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site 1552
state: Oregon
city: Beaver
country: United States
facility: Forest Investigative Site 1574
state: Pennsylvania
city: Beaver
country: United States
facility: Forest Investigative Site 1577
state: Pennsylvania
city: Bethlehem
country: United States
facility: Forest Investigative Site 1126
state: Pennsylvania
city: Erie
country: United States
facility: Forest Investigative Site 1423
state: Pennsylvania
city: Hershey
country: United States
facility: Forest Investigative Site 1504
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 1569
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 1548
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 1146
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 1560
state: Pennsylvania
city: Tipton
country: United States
facility: Forest Investigative Site 1449
state: Pennsylvania
city: Uniontown
country: United States
facility: Forest Investigative Site 1564
state: Pennsylvania
city: Johnston
country: United States
facility: Forest Investigative Site 1144
state: Rhode Island
city: Charleston
country: United States
facility: Forest Investigative Site 2072
state: South Carolina
city: Easley
country: United States
facility: Forest Investigative Site 1568
state: South Carolina
city: Greenville
country: United States
facility: Forest Investigative Site 1506
state: South Carolina
city: Greer
country: United States
facility: Forest Investigative Site 1601
state: South Carolina
city: Spartanburg
country: United States
facility: Forest Investigative Site 0900
state: South Carolina
city: Union
country: United States
facility: Forest Investigative Site 1450
state: South Carolina
city: Rapid City
country: United States
facility: Forest Investigative Site 1365
state: South Dakota
city: Arlington
country: United States
facility: Forest Investigative Site 1440
state: Texas
city: Austin
country: United States
facility: Forest Investigative Site 1954
state: Texas
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: Fort Worth
country: United States
facility: Forest Investigative Site 2012
state: Texas
city: Killeen
country: United States
facility: Forest Investigative Site 1902
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 1498
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 1614
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 1906
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 2004
state: Texas
city: Magna
country: United States
facility: Forest Investigative Site 1600
state: Utah
city: Abingdon
country: United States
facility: Forest Investigative Site 1480
state: Virginia
city: Alexandria
country: United States
facility: Forest Investigative Site 1579
state: Virginia
city: Spokane
country: United States
facility: Forest Investigative Site 1142
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 1573
state: Washington
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References:
citation: Donohue JF, Soong W, Wu X, Shrestha P, Lei A. Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: Results of a randomized 1-year trial in patients with COPD. Respir Med. 2016 Jul;116:41-8. doi: 10.1016/j.rmed.2016.05.007. Epub 2016 May 7.