Clinical trial NCT00419952: A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
Official title: A 52-week, Randomised, Double-blind, Parallel-group, Multi-centre, Phase IIIB Study Comparing the Long Term Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily to Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily in Adult/Adolescent (≥12 Years) African American Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Moderate Asthma
Severe Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 742
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
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 the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.


Eligibility criteria: Inclusion Criteria:

* Male or Female, African American (self-reported), ≥12 years of age
* Moderate to severe asthma requiring treatment with an inhaled corticosteroid
* Diagnosis of asthma for at least 6 months

Exclusion Criteria:

* Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
* Any significant disease or disorder that may jeopardize a subject's safety

Primary outcomes:
measure: Total Number of Asthma Exacerbations
timeFrame: 52 Weeks
Secondary outcomes:
measure: Asthma Exacerbations
timeFrame: 52 Weeks
measure: QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)
timeFrame: Baseline and 52 weeks
measure: Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment
timeFrame: Baseline and 2 weeks (visit 4)
measure: Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment
timeFrame: Baseline and 2 weeks (visit 4)
measure: Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment
timeFrame: Baseline and 2 weeks (visit 4)
measure: Diary Assessments - Rescue-free Day
timeFrame: baseline and 52 weeks
measure: Diary Assessments - Symptom-free Day
timeFrame: baseline and 52 weeks
measure: Diary Assessments - Asthma-control Day
timeFrame: baseline and 52 weeks
measure: Onset of Effect Questionnaire (OEQ)
timeFrame: 1 week
measure: Onset of Effect Questionnaire (OEQ)
timeFrame: 1 week
measure: Peak Expiratory Flow (PEF) in Morning
timeFrame: baseline and 52 weeks
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: baseline and 52 weeks
measure: Asthma Treatment Satisfaction Measure (ATSM)
timeFrame: Baseline and 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Montgomery
country: United States
facility: Research Site
state: Alabama
city: Muscle Shoals
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Buena Park
country: United States
facility: Research Site
state: California
city: Foothill Ranch
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Rolling Hills Estates
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Stockton
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Winnetka
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Destin
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Opa Locka
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Pensacola
country: United States
facility: Research Site
state: Florida
city: Port Charlotte
country: United States
facility: Research Site
state: Florida
city: South Miami
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Albany
country: United States
facility: Research Site
state: Georgia
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Columbus
country: United States
facility: Research Site
state: Georgia
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Stone Mountain
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Peoria
country: United States
facility: Research Site
state: Illinois
city: River Forest
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Merrillville
country: United States
facility: Research Site
state: Indiana
city: South Bend
country: United States
facility: Research Site
state: Indiana
city: Topeka
country: United States
facility: Research Site
state: Kansas
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Owensboro
country: United States
facility: Research Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Bogalusa
country: United States
facility: Research Site
state: Louisiana
city: Marrero
country: United States
facility: Research Site
state: Louisiana
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: Monroe
country: United States
facility: Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Sunset
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Mitchellville
country: United States
facility: Research Site
state: Maryland
city: Montgomery Village
country: United States
facility: Research Site
state: Maryland
city: Wheaton
country: United States
facility: Research Site
state: Maryland
city: Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Bay City
country: United States
facility: Research Site
state: Michigan
city: Paw Paw
country: United States
facility: Research Site
state: Michigan
city: Saginaw
country: United States
facility: Research Site
state: Michigan
city: Southfield
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Prentiss
country: United States
facility: Research Site
state: Mississippi
city: Vicksburg
country: United States
facility: Research Site
state: Mississippi
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Blackwood
country: United States
facility: Research Site
state: New Jersey
city: Cherry Hill
country: United States
facility: Research Site
state: New Jersey
city: Teaneck
country: United States
facility: Research Site
state: New Jersey
city: Verona
country: United States
facility: Research Site
state: New Jersey
city: Bronx
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Newburgh
country: United States
facility: Research Site
state: New York
city: North Syracuse
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Tonawanda
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: Highpoint
country: United States
facility: Research Site
state: North Carolina
city: Mooresville
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Lyndhurst
country: United States
facility: Research Site
state: Ohio
city: Parma
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Beaver
country: United States
facility: Research Site
state: Pennsylvania
city: Collegeville
country: United States
facility: Research Site
state: Pennsylvania
city: Harrisburg
country: United States
facility: Research Site
state: Pennsylvania
city: Havertown
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Upland
country: United States
facility: Research Site
state: Pennsylvania
city: Yardley
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Gaffney
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Simpsonville
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Union
country: United States
facility: Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Killeen
country: United States
facility: Research Site
state: Texas
city: Missouri City
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Sugar Land
country: United States
facility: Research Site
state: Texas
city: Sugarland
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Hampton
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Springfield
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: AstraZeneca
name: Christer Hultquist, MD
role: STUDY_DIRECTOR
References: