Clinical trial NCT01572792: Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment 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: 2012-04-06
Enrollment: 921
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 Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.


Eligibility criteria: Inclusion Criteria:

* Completion of the treatment phase of the lead-in study, LAC-MD-31
* Written informed consent obtained from the patient before the initiation of any study specific procedures
* No medical contraindication as judged by the PI
* Compliance with LAC-MD-31 study procedures and IP dosing.

Exclusion Criteria:

* No specific exclusion criteria

Primary outcomes:
measure: Percentage of Patients to Experience Any Treatment-emergent Adverse Event
timeFrame: Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)
Secondary outcomes:
measure: Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis
timeFrame: Baseline of lead-in study to end of treatment (up to Week 52)
measure: Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value
timeFrame: Baseline of lead-in study to end of treatment (up to Week 52)
measure: Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)
timeFrame: Baseline of lead-in study to end of treatment (up to Week 52)
Other outcomes:
measure: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline of lead-in study to Week 52 of treatment
measure: Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline of lead-in study to Week 52 of treatment
measure: Transition Dyspnea Index (TDI) Focal Score at End of Study
timeFrame: Baseline of lead-in study to Week 52 of treatment
measure: Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: Baseline of lead-in study to Week 52 of treatment
Locations:
city: Anniston
country: United States
facility: Forest Investigative Site 1827
state: Alabama
city: Athens
country: United States
facility: Forest Investigative Site 1920
state: Alabama
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 1937
state: Alabama
city: Gulf Shores
country: United States
facility: Forest Investigative Site 1824
state: Alabama
city: Jasper
country: United States
facility: Forest Investigative Site 2088
state: Alabama
city: Scottsboro
country: United States
facility: Forest Investigative Site 1918
state: Alabama
city: Glendale
country: United States
facility: Forest Investigative Site 0909
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 1379
state: Arizona
city: Anaheim
country: United States
facility: Forest Investigative Site 1822
state: California
city: Buena Park
country: United States
facility: Forest Investigative Site 1483
state: California
city: Fresno
country: United States
facility: Forest Investigative Site 1156
state: California
city: Lincoln
country: United States
facility: Forest Investigative Site 1871
state: California
city: Los Angeles
country: United States
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state: California
city: Riverside
country: United States
facility: Forest Investigative Site 2064
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 1427
state: California
city: Sacramento
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state: California
city: San Diego
country: United States
facility: Forest Investigative Site 1125
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 2009
state: California
city: Torrance
country: United States
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state: California
city: Tustin
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state: California
city: Vista
country: United States
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state: California
city: Golden
country: United States
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state: Colorado
city: Pueblo
country: United States
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state: Colorado
city: Wheat Ridge
country: United States
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state: Colorado
city: Waterbury
country: United States
facility: Forest Investigative Site 1976
state: Connecticut
city: Bay Pines
country: United States
facility: Forest Investigative Site 1821
state: Florida
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 1364
state: Florida
city: Clearwater
country: United States
facility: Forest Investigative Site 1152
state: Florida
city: Clearwater
country: United States
facility: Forest Investigative Site 1875
state: Florida
city: Covington
country: United States
facility: Forest Investigative Site 1811
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: Hialeah
country: United States
facility: Forest Investigative Site 1854
state: Florida
city: Hollywood
country: United States
facility: Forest Investigative Site 1882
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 1543
state: Florida
city: Kissimmee
country: United States
facility: Forest Investigative Site 1416
state: Florida
city: Melbourne
country: United States
facility: Forest Investigative Site 1167
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 1432
state: Florida
city: N. Miami
country: United States
facility: Forest Investigative Site 1808
state: Florida
city: Naples
country: United States
facility: Forest Investigative Site 1819
state: Florida
city: Oldsmar
country: United States
facility: Forest Investigative Site 1950
state: Florida
city: Ormond Beach
country: United States
facility: Forest Investigative Site 1145
state: Florida
city: Panama City
country: United States
facility: Forest Investigative Site 1094
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 1803
state: Florida
city: Pensacola
country: United States
facility: Forest Investigative Site 0974
state: Florida
city: Sarasota
country: United States
facility: Forest Investigative Site 1817
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative Site 1874
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site 2082
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 2053
state: Florida
city: Tampa
country: United States
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 1860
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 1900
state: Georgia
city: Austell
country: United States
facility: Forest Investigative Site 0987
state: Georgia
city: Canton
country: United States
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state: Georgia
city: Marietta
country: United States
facility: Forest Investigative Site 1830
state: Georgia
city: Woodstock
country: United States
facility: Forest Investigative Site 2089
state: Georgia
city: Coeur d Alene
country: United States
facility: Forest Investigative Site 0679
state: Idaho
city: Eagle
country: United States
facility: Forest Investigative Site 1858
state: Idaho
city: Normal
country: United States
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state: Illinois
city: Normal
country: United States
facility: Forest Investigative Site 1912
state: Illinois
city: River Forest
country: United States
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state: Illinois
city: Bowling Green
country: United States
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city: Fort Mitchell
country: United States
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state: Kentucky
city: Lexington
country: United States
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state: Kentucky
city: Louisville
country: United States
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country: United States
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country: United States
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state: Louisiana
city: Opelousas
country: United States
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state: Louisiana
city: Bangor
country: United States
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state: Maine
city: Baltimore
country: United States
facility: Forest Investigative Site 1924
state: Maryland
city: Wheaton
country: United States
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state: Maryland
city: Fall River
country: United States
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state: Massachusetts
city: Fall River
country: United States
facility: Forest Investigative Site 1852
state: Massachusetts
city: No. Dartmouth
country: United States
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state: Massachusetts
city: Ann Arbor
country: United States
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state: Michigan
city: Stevensville
country: United States
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state: Michigan
city: Troy
country: United States
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state: Michigan
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country: United States
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state: Minnesota
city: Fridley
country: United States
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state: Minnesota
city: Minneapolis
country: United States
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city: Minneapolis
country: United States
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city: Plymouth
country: United States
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state: Minnesota
city: Rochester
country: United States
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state: Minnesota
city: Olive Branch
country: United States
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state: Mississippi
city: Kansas City
country: United States
facility: Forest Investigative Site 1602
state: Missouri
city: N. Chesterfield
country: United States
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state: Missouri
city: Springfield
country: United States
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city: Springfield
country: United States
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state: Missouri
city: St. Charles
country: United States
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state: Missouri
city: St. Louis
country: United States
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country: United States
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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: Fremont
country: United States
facility: Forest Investigative Site 1948
state: Nebraska
city: Lincoln
country: United States
facility: Forest Investigative Site 1815
state: Nebraska
city: Omaha
country: United States
facility: Forest Investigative Site 1363
state: Nebraska
city: Omaha
country: United States
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state: Nebraska
city: Omaha
country: United States
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state: Nebraska
city: Omaha
country: United States
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state: Nebraska
city: Omaha
country: United States
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state: Nebraska
city: Henderson
country: United States
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state: Nevada
city: Las Vegas
country: United States
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state: Nevada
city: Las Vegas
country: United States
facility: Forest Investigative Site 1562
state: Nevada
city: Cherry Hill
country: United States
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state: New Jersey
city: Hackensack
country: United States
facility: Forest Investigative Site 1923
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 1949
state: New Mexico
city: Great Neck
country: United States
facility: Forest Investigative Site 1151
state: New York
city: Larchmont
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 1392
state: North Carolina
city: Elizabeth City
country: United States
facility: Forest Investigative Site 2035
state: North Carolina
city: High Point
country: United States
facility: Forest Investigative Site 1366
state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Salisbury
country: United States
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city: Cadiz
country: United States
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state: Ohio
city: Canton
country: United States
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state: Ohio
city: Cincinnati
country: United States
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city: Cincinnati
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state: Ohio
city: Cincinnati
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facility: Forest Investigative Site 2028
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 1903
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city: Columbus
country: United States
facility: Forest Investigative Site 1361
state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Sylvania
country: United States
facility: Forest Investigative Site 2090
state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Zanesville
country: United States
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state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 1915
state: Oklahoma
city: Bend
country: United States
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state: Oregon
city: Medford
country: United States
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state: Oregon
city: Altoona
country: United States
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state: Pennsylvania
city: Downington
country: United States
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state: Pennsylvania
city: Erie
country: United States
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state: Pennsylvania
city: Langhorne
country: United States
facility: Forest Investigative Site 1899
state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Phoenixville
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 1146
state: Pennsylvania
city: Tipton
country: United States
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state: Pennsylvania
city: Uniontown
country: United States
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state: Pennsylvania
city: Cumberland
country: United States
facility: Forest Investigative Site 1832
state: Rhode Island
city: East Providence
country: United States
facility: Forest Investigative Site 1089
state: Rhode Island
city: Charleston
country: United States
facility: Forest Investigative Site 2072
state: South Carolina
city: Charleston
country: United States
facility: Forest Investigative Site 1905
state: South Carolina
city: Charleston
country: United States
facility: Forest Investigative Site 1802
state: South Carolina
city: Fort Mill
country: United States
facility: Forest Investigative Site 1914
state: South Carolina
city: Gaffney
country: United States
facility: Forest Investigative Site 1913
state: South Carolina
city: Spartanburg
country: United States
facility: Forest Investigative Site 1121
state: South Carolina
city: Brentwood
country: United States
facility: Forest Investigative Site 1957
state: Tennessee
city: Fayetteville
country: United States
facility: Forest Investigative Site 1526
state: Tennessee
city: Arlington
country: United States
facility: Forest Investigative Site 1440
state: Texas
city: Boerne
country: United States
facility: Forest Investigative Site 1879
state: Texas
city: Carrollton
country: United States
facility: Forest Investigative Site 1861
state: Texas
city: Corsicana
country: United States
facility: Forest Investigative Site 1816
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 1890
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: Houston
country: United States
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state: Texas
city: McKinney
country: United States
facility: Forest Investigative Site 1091
state: Texas
city: Plano
country: United States
facility: Forest Investigative Site 1826
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Salt Lake City
country: United States
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state: Utah
city: South Burlington
country: United States
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state: Vermont
city: Newport News
country: United States
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state: Virginia
city: Norfolk
country: United States
facility: Forest Investigative Site 1404
state: Virginia
city: Bellingham
country: United States
facility: Forest Investigative Site 1120
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 1977
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 1878
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 1573
state: Washington
city: Tacoma
country: United States
facility: Forest Investigative Site 0988
state: Washington
city: Tacoma
country: United States
facility: Forest Investigative Site 1870
state: Washington
city: Morgantown
country: United States
facility: Forest Investigative Site 1555
state: West Virginia
city: New Lambton
country: Australia
facility: Forest Investigative Site 1991
state: New South Wales
city: Redcliffe
country: Australia
facility: Forest Investigative Site 1987
state: Queensland
city: Woolloongabba
country: Australia
facility: Forest Investigative Site 1973
state: Queensland
city: Adelaide
country: Australia
facility: Forest Investigative Site 2253
state: South Australia
city: Bedford Park
country: Australia
facility: Forest Investigative Site 1981
state: South Australia
city: Daw Park
country: Australia
facility: Forest Investigative Site 1990
state: South Australia
city: Toorak Gardens
country: Australia
facility: Forest Investigative Site 2251
state: South Australia
city: Clayton
country: Australia
facility: Forest Investigative Site 2250
state: Victoria
city: Fitzroy
country: Australia
facility: Forest Investigative Site 1972
state: Victoria
city: Geelong
country: Australia
facility: Forest Investigative Site 1986
state: Victoria
city: Parkville
country: Australia
facility: Forest Investigative Site 1985
state: Victoria
city: Langley
country: Canada
facility: Forest Investigative Site 1904
state: British Columbia
city: Vancouver
country: Canada
facility: Forest Investigative Site 905
state: British Columbia
city: Winnipeg
country: Canada
facility: Forest Investigative Site 0976
state: Manitoba
city: Sarina
country: Canada
facility: Forest Investigative Site 1877
state: Ontario
city: Sarnia
country: Canada
facility: Forest Investigative Site 1896
state: Ontario
city: Toronto
country: Canada
facility: Forest Investigative Site 1171
state: Ontario
city: Toronto
country: Canada
facility: Forest Investigative Site 2203
state: Ontario
city: Montreal
country: Canada
facility: Forest Investigative Site 1952
state: Quebec
city: Saskatoon
country: Canada
facility: Forest Investigative Site 0943
state: Saskatchewan
city: Quebec
country: Canada
facility: Forest Investigative Site 1859
city: Auckland
country: New Zealand
facility: Forest Investigative Site 1027
city: Christchurch
country: New Zealand
facility: Forest Investigative Site 1970
city: Dunedin
country: New Zealand
facility: Forest Investigative Site 1967
city: Dunedin
country: New Zealand
facility: Forest Investigative Site 1964
city: Hamilton
country: New Zealand
facility: Forest Investigative Site 1968
city: Tauranga
country: New Zealand
facility: Forest Investigative Site 1965
city: Tauranga
country: New Zealand
facility: Forest Investigative Site 1980
city: Wellington
country: New Zealand
facility: Forest Investigative Site 1025
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References:
citation: D'Urzo A, Rennard S, Kerwin E, Donohue JF, Lei A, Molins E, Leselbaum A. A randomised double-blind, placebo-controlled, long-term extension study of the efficacy, safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease. Respir Med. 2017 Apr;125:39-48. doi: 10.1016/j.rmed.2017.02.008. Epub 2017 Feb 16.