Back to resultsA Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Budesonide/formoterol (SYMBICORT) pMDI
Budesonide HFA pMDI
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Moderate Asthma, Severe Asthma
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Symbicort
Budesonide
Arm Description
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Budesonide HFA pMDI 160 ug x 2 actuations BID
Outcomes
Primary Outcome Measures
Total Number of Asthma Exacerbations
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.
Secondary Outcome Measures
Asthma Exacerbations
Number of participants with at least 1 exacerbation
QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)
QT interval corrected using the Fridericia formula [QTc (Frid)] - Change from baseline to end of treatment
Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment
Total ectopic ventricular (VE) beats - number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4.
Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment
Total ectopic supraventricular (VE) beats - number of participants with shift normal (<50) to high (≥50) from baseline to visit 4.
Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment
Total ventricular runs - number of participants with shift normal (<1) to high (≥1) from baseline to week 2.
Diary Assessments - Rescue-free Day
Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered "no" to having used rescue medication that day
Diary Assessments - Symptom-free Day
Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered "no" to having symptoms that day
Diary Assessments - Asthma-control Day
Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered "no" to having symptoms and "0" to the use of rescue medication that day
Onset of Effect Questionnaire (OEQ)
Number of participants with positive response to Item 2 in questionnaire "During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Onset of Effect Questionnaire (OEQ)
Number of participants with positive response to Item 5 in questionnaire "During the past week, you were satisfied with how quickly you felt your study medication begin to work." The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Peak Expiratory Flow (PEF) in Morning
Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.
Forced Expiratory Volume in One Second (FEV1)
Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period
Asthma Treatment Satisfaction Measure (ATSM)
Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419952
Brief Title
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
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Moderate Asthma, Severe Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
742 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Symbicort
Arm Type
Experimental
Arm Description
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Arm Title
Budesonide
Arm Type
Experimental
Arm Description
Budesonide HFA pMDI 160 ug x 2 actuations BID
Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol (SYMBICORT) pMDI
Intervention Description
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Budesonide HFA pMDI
Intervention Description
Budesonide HFA pMDI 160 ug x 2 actuations BID
Primary Outcome Measure Information:
Title
Total Number of Asthma Exacerbations
Description
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Asthma Exacerbations
Description
Number of participants with at least 1 exacerbation
Time Frame
52 Weeks
Title
QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)
Description
QT interval corrected using the Fridericia formula [QTc (Frid)] - Change from baseline to end of treatment
Time Frame
Baseline and 52 weeks
Title
Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment
Description
Total ectopic ventricular (VE) beats - number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4.
Time Frame
Baseline and 2 weeks (visit 4)
Title
Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment
Description
Total ectopic supraventricular (VE) beats - number of participants with shift normal (<50) to high (≥50) from baseline to visit 4.
Time Frame
Baseline and 2 weeks (visit 4)
Title
Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment
Description
Total ventricular runs - number of participants with shift normal (<1) to high (≥1) from baseline to week 2.
Time Frame
Baseline and 2 weeks (visit 4)
Title
Diary Assessments - Rescue-free Day
Description
Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered "no" to having used rescue medication that day
Time Frame
baseline and 52 weeks
Title
Diary Assessments - Symptom-free Day
Description
Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered "no" to having symptoms that day
Time Frame
baseline and 52 weeks
Title
Diary Assessments - Asthma-control Day
Description
Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered "no" to having symptoms and "0" to the use of rescue medication that day
Time Frame
baseline and 52 weeks
Title
Onset of Effect Questionnaire (OEQ)
Description
Number of participants with positive response to Item 2 in questionnaire "During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Time Frame
1 week
Title
Onset of Effect Questionnaire (OEQ)
Description
Number of participants with positive response to Item 5 in questionnaire "During the past week, you were satisfied with how quickly you felt your study medication begin to work." The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Time Frame
1 week
Title
Peak Expiratory Flow (PEF) in Morning
Description
Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.
Time Frame
baseline and 52 weeks
Title
Forced Expiratory Volume in One Second (FEV1)
Description
Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period
Time Frame
baseline and 52 weeks
Title
Asthma Treatment Satisfaction Measure (ATSM)
Description
Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.
Time Frame
Baseline and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christer Hultquist, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Muscle Shoals
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Buena Park
State/Province
California
Country
United States
Facility Name
Research Site
City
Foothill Ranch
State/Province
California
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Riverside
State/Province
California
Country
United States
Facility Name
Research Site
City
Rolling Hills Estates
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Stockton
State/Province
California
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
Country
United States
Facility Name
Research Site
City
Winnetka
State/Province
California
Country
United States
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Research Site
City
Altamonte Springs
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Destin
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Opa Locka
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
Research Site
City
South Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Albany
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Stone Mountain
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
River Forest
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Merrillville
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Bogalusa
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Marrero
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Monroe
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Sunset
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Mitchellville
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Montgomery Village
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Bay City
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Paw Paw
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Saginaw
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Southfield
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Prentiss
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
Vicksburg
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Blackwood
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Cherry Hill
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Teaneck
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Verona
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Newburgh
State/Province
New York
Country
United States
Facility Name
Research Site
City
North Syracuse
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Tonawanda
State/Province
New York
Country
United States
Facility Name
Research Site
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Highpoint
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Mooresville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Lyndhurst
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Parma
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Beaver
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Collegeville
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Harrisburg
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Havertown
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Upland
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Yardley
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Gaffney
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Union
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Killeen
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Missouri City
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Sugar Land
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Sugarland
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Waco
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Hampton
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.asthmaclinicaltrials.com
Description
Related Info
Learn more about this trial
A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
We'll reach out to this number within 24 hrs