Clinical trial NCT00206167: A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
Official title: A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 1600
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 compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of COPD with symptoms for more than 2 years.
* Smoking history of 10 or more pack years
* A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion Criteria:

* A history of asthma
* Patients taking oral steroids
* Any significant disease or disorder that may jeopardize the safety of the patient

Primary outcomes:
measure: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
Secondary outcomes:
measure: Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
measure: Health care utilization
measure: Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
measure: all variables assessed over the 12 months treatment period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Jasper
country: United States
facility: Research Site
state: Alabama
city: Muscle Shoals
country: United States
facility: Research Site
state: Alabama
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Fort Smith
country: United States
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state: Arkansas
city: Carmichael
country: United States
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state: California
city: La Jolla
country: United States
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state: California
city: Lakewood
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state: California
city: Los Angeles
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state: California
city: Murrieta
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state: California
city: Palo Alto
country: United States
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state: California
city: Peninsula
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state: California
city: Pismo Beach
country: United States
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city: Rancho Mirage
country: United States
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state: California
city: Riverside
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city: Sacramento
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city: San Diego
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city: Santa Ana
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city: Stockton
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state: California
city: Walnut Creek
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Hartford
country: United States
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state: Connecticut
city: Bay Pines
country: United States
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state: Florida
city: Clearwater
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state: Florida
city: Deland
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city: Largo
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city: Longwood
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city: Miami
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city: New Port Richey
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city: Ormond Beach
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city: Panama City
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city: Atlanta
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state: Georgia
city: Blue Ridge
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city: Conyers
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city: Decatur
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city: Elk Grove Village
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city: Normal
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city: North Chicago
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city: O'Fallon
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city: Peoria
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city: Springfield
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city: Evansville
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city: Indianapolis
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city: South Bend
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city: Council Bluffs
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city: Iowa City
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city: Waterloo
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city: Bowling Green
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city: Lebanon
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city: Louisville
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city: Kenner
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city: Lafayette
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city: Shreveport
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city: Slidell
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state: Maine
city: Bangor
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city: Taunton
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city: Cadillac
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city: Portage
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city: Saginaw
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city: Edina
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city: Minneapolis
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city: St. Charles
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state: Missouri
city: St. Louis
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state: Missouri
city: Missoula
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state: Montana
city: McCook
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city: Omaha
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state: Nebraska
city: Scottsbluff
country: United States
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state: Nebraska
city: Henderson
country: United States
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state: Nevada
city: Las Vegas
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state: Nevada
city: Pahrump
country: United States
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state: Nevada
city: Berlin
country: United States
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state: New Jersey
city: Cherry Hill
country: United States
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city: Turnersville
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city: Albany
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city: Cortland
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city: Elmira
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city: Ithaca
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city: New Hyde Park
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city: Rochester
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city: Tonawanda
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city: High Point
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state: North Carolina
city: Winston-Salem
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city: Cincinnati
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city: Portland
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city: Elverson
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city: Philadelphia
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city: East Providence
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state: Rhode Island
city: Providence
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state: Rhode Island
city: Anderson
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state: South Carolina
city: Charleston
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city: Gaffney
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city: Greenville
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city: Greer
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city: Spartanburg
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state: Tennessee
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city: Dallas
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city: El Paso
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city: Fort Worth
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city: Provo
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state: Utah
city: Salt Lake City
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state: Virginia
city: Richmond
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city: Spokane
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state: Washington
city: Pleven
country: Bulgaria
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city: Plovdiv
country: Bulgaria
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city: Rousse
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Varna
country: Bulgaria
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city: Aalborg
country: Denmark
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city: Christiansfeld
country: Denmark
facility: Research Site
city: Frederikshavn
country: Denmark
facility: Research Site
city: Frederikssund
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
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city: Kobenhavn K
country: Denmark
facility: Research Site
city: Kobenhavn NV
country: Denmark
facility: Research Site
city: Kobenhavn N
country: Denmark
facility: Research Site
city: Kobenhavn S.
country: Denmark
facility: Research Site
city: Silkeborg
country: Denmark
facility: Research Site
city: Skive
country: Denmark
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city: Svendborg
country: Denmark
facility: Research Site
city: Vaerlose
country: Denmark
facility: Research Site
city: Viborg
country: Denmark
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
state: Brandenburg
city: Dusseldorf
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Research Site
state: Sachsen
city: Jena-Maua
country: Germany
facility: Research Site
state: Thüringen
city: Bad Salzungen
country: Germany
facility: Research Site
city: Bad Segeberg
country: Germany
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city: Berlin
country: Germany
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city: Bochum
country: Germany
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city: Bonn
country: Germany
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city: Erfurt
country: Germany
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city: Frankfurt
country: Germany
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city: Freiburg
country: Germany
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city: Geesthacht
country: Germany
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city: Gelnhausen
country: Germany
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city: Gelsenkirchen
country: Germany
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city: Grobhansdorf
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
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city: Mainz
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Neuruppin
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Hraklion- Crete
country: Greece
facility: Research Site
city: Larisa
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cegled
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Erd
country: Hungary
facility: Research Site
city: Fuzesabony
country: Hungary
facility: Research Site
city: Godolli
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Gyöngyös
country: Hungary
facility: Research Site
city: Jaszbereny
country: Hungary
facility: Research Site
city: Keszthely
country: Hungary
facility: Research Site
city: Kiskunhalas
country: Hungary
facility: Research Site
city: Mosdos
country: Hungary
facility: Research Site
city: Mosonmagyarovar
country: Hungary
facility: Research Site
city: Nógrádgárdony
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Salgótarján
country: Hungary
facility: Research Site
city: Siofok
country: Hungary
facility: Research Site
city: Szarvas
country: Hungary
facility: Research Site
city: Szazhalombatta
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Sárvár
country: Hungary
facility: Research Site
city: Tatabanya
country: Hungary
facility: Research Site
city: Törökbálint
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
city: Zalaegerszeg-Pozva
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Reykjavik
country: Iceland
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
state: D.f.
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Deva
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
citation: Make BJ, Eriksson G, Calverley PM, Jenkins CR, Postma DS, Peterson S, Ostlund O, Anzueto A. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015 Jan 27;10:201-9. doi: 10.2147/COPD.S69589. eCollection 2015.
citation: Bleecker ER, Meyers DA, Bailey WC, Sims AM, Bujac SR, Goldman M, Martin UJ. ADRB2 polymorphisms and budesonide/formoterol responses in COPD. Chest. 2012 Aug;142(2):320-328. doi: 10.1378/chest.11-1655.