Clinical trial NCT00419744: A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
Official title: A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 1200
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 determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.


Eligibility criteria: Inclusion Criteria:

* A current clinical diagnosis of COPD with COPD symptoms for more than 2 years
* Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
* A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit

Exclusion Criteria:

* A history of asthma at or after 18 years of age
* A history of allergic rhinitis at or after 18 years of age
* Subjects taking oral steroids
* Any significant disease or disorder that may jeopardize a subject's safety

Primary outcomes:
measure: Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
timeFrame: 12 months
measure: Rate of Exacerbations Per Subject-year
timeFrame: 12 months
Secondary outcomes:
measure: Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 12 months
measure: Morning Peak Expiratory Flow (PEF)
timeFrame: 12 months
measure: Evening PEF
timeFrame: 12 months
measure: Dyspnea Symptom Scores
timeFrame: 12 months
measure: Use of Rescue Medication
timeFrame: 12 months
measure: St. George's Respiratory Questionnaire (SGRQ) Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Jasper
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Fort Smith
country: United States
facility: Research Site
state: Arkansas
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Foothill Ranch
country: United States
facility: Research Site
state: California
city: Fullerton
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
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state: California
city: Los Angeles
country: United States
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state: California
city: Los Banos
country: United States
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state: California
city: Mission Viejo
country: United States
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state: California
city: Pismo Beach
country: United States
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state: California
city: Rancho Cordova
country: United States
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state: California
city: Rancho Mirage
country: United States
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state: California
city: Riverside
country: United States
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state: California
city: Rolling Hills Estates
country: United States
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state: California
city: Sacramento
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: Sepulveda
country: United States
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state: California
city: Torrance
country: United States
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state: California
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Wheat Ridge
country: United States
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state: Colorado
city: Stanford
country: United States
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state: Connecticut
city: Deland
country: United States
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state: Florida
city: Opalocka
country: United States
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state: Florida
city: Orange City
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Panama City
country: United States
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city: Pensacola
country: United States
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city: Sarasota
country: United States
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city: St Cloud
country: United States
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state: Florida
city: Augusta
country: United States
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state: Georgia
city: Blue Ridge
country: United States
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state: Georgia
city: Marietta
country: United States
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state: Georgia
city: Boise
country: United States
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city: Coeur D'alene
country: United States
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city: Chicago
country: United States
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state: Illinois
city: Council Bluffs
country: United States
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city: Witchita
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city: Marrero
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city: Metairie
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city: Sunset
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city: Bangor
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state: Maine
city: Pittsfield
country: United States
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city: Waltham
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city: Chesterfield
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state: Missouri
city: Florissant
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city: Kansas City
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city: St. Louis
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city: Missoula
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city: Omaha
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city: Papillion
country: United States
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city: Las Vegas
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state: Nevada
city: Springfield
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city: Bronxville
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city: Elmira
country: United States
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city: Larchmont
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state: New York
city: Charlotte
country: United States
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state: North Carolina
city: Elizabeth City
country: United States
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city: Hickory
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state: North Carolina
city: Chardon
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state: Ohio
city: Cincinnati
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city: Columbus
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city: Sylvania
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city: Oklahoma City
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city: Medford
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city: Portland
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city: Beaver
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state: Pennsylvania
city: Bensalem
country: United States
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state: Pennsylvania
city: Downingtown
country: United States
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state: Pennsylvania
city: Harrisburg
country: United States
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state: Pennsylvania
city: Landsdale
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Warminster
country: United States
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state: Pennsylvania
city: Yardley
country: United States
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state: Pennsylvania
city: East Providence
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state: Rhode Island
city: Charleston
country: United States
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state: South Carolina
city: Gaffney
country: United States
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state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Prosperity
country: United States
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state: South Carolina
city: Spartanburg
country: United States
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state: South Carolina
city: Union
country: United States
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state: South Carolina
city: Fayetteville
country: United States
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state: Tennessee
city: Boerne
country: United States
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city: Houston
country: United States
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city: McKinney
country: United States
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city: San Antonio
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city: Abingdon
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state: Virginia
city: Spokane
country: United States
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state: Washington
city: Tacoma
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state: Washington
city: 9 de Julio
country: Argentina
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state: Buenos Aires
city: Capital Federal
country: Argentina
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state: Buenos Aires
city: Mar Del Plata
country: Argentina
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state: Buenos Aires
city: Ramos Mejia
country: Argentina
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state: Buenos Aires
city: Vicente Lopez
country: Argentina
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state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
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state: Tucuman
city: Cordoba
country: Argentina
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city: Corrientes
country: Argentina
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city: Mendoza
country: Argentina
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city: San Juan
country: Argentina
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
state: CE
city: Goiania
country: Brazil
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state: GO
city: Recife
country: Brazil
facility: Research Site
state: Pernambuco
city: Curitiba
country: Brazil
facility: Research Site
state: PR
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Porta Alegre
country: Brazil
facility: Research Site
state: RS
city: Florian�polis
country: Brazil
facility: Research Site
state: Santa Catarina
city: Santo Andre
country: Brazil
facility: Research Site
state: SP
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Valparaiso
country: Chile
facility: Research Site
state: Quinta Region
city: Santiago
country: Chile
facility: Research Site
state: RM
city: Rancagua
country: Chile
facility: Research Site
state: Vi Region
city: Medillin
country: Colombia
facility: Research Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Research Site
state: Atl�ntico
city: Bogota Dc
country: Colombia
facility: Research Site
state: Cundianmarca
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Jesus Maria
country: Peru
facility: Research Site
state: Lima
city: San Borja
country: Peru
facility: Research Site
state: Lima
city: Surco
country: Peru
facility: Research Site
state: Lima
city: Lima
country: Peru
facility: Research Site
city: Belvilee
country: South Africa
facility: Research Site
state: Cape Town
city: Tygerberg
country: South Africa
facility: Research Site
state: Cape Town
city: Port Elizabeth
country: South Africa
facility: Research Site
state: E Cape
city: Korsten
country: South Africa
facility: Research Site
state: Port Elizabeth
city: Groenkloof
country: South Africa
facility: Research Site
state: Pretoria
city: Thaba Tswane
country: South Africa
facility: Research Site
state: Pretoria
city: Amanzimtoti
country: South Africa
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Boksburg
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Centurion
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Humansdorp
country: South Africa
facility: Research Site
city: Pretoria West
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Roodepoort
country: South Africa
facility: Research Site
city: Distrito Capital
country: Venezuela
facility: Research Site
state: Caracas
Study officials:
affiliation: AstraZeneca
name: Christer Hultquist, 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: Jenkins CR, Postma DS, Anzueto AR, Make BJ, Peterson S, Eriksson G, Calverley PM. Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease. BMC Pulm Med. 2015 Aug 21;15:97. doi: 10.1186/s12890-015-0077-0.
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: Sharafkhaneh A, Southard JG, Goldman M, Uryniak T, Martin UJ. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respir Med. 2012 Feb;106(2):257-68. doi: 10.1016/j.rmed.2011.07.020. Epub 2011 Oct 26.