Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans
Titan
A 12-wk, Rand., Double-blind, Double Dummy, Multi-ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort® (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma
1 other identifier
interventional
311
1 country
57
Brief Summary
To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Jun 2008
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
November 9, 2012
CompletedNovember 9, 2012
October 1, 2012
1.3 years
June 19, 2008
September 20, 2010
October 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period
Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Baseline to 12 weeks
Secondary Outcomes (23)
Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period
Baseline to 12 weeks
Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period
Baseline to 12 weeks
Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period
Baseline to 12 weeks
Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period
Baseline to 12 weeks
Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry
12 weeks
- +18 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
160/4.5 μg x 2 actuations twice daily (bid)
Eligibility Criteria
You may qualify if:
- African American (self-reported)
- Documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 2 and be in stable condition.
- FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after LABA, of 45%-85%, inclusive, of predicted normal.
You may not qualify if:
- Has been hospitalized at least once for an asthma related condition during the 6 months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2.
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit 2.
- Has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (57)
Research Site
Pell City, Alabama, United States
Research Site
Bentonville, Arkansas, United States
Research Site
Hot Springs, Arkansas, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Malvern, Arkansas, United States
Research Site
Huntington Park, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angles, California, United States
Research Site
Orange, California, United States
Research Site
Rolling Hills Estates, California, United States
Research Site
Centennial, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Inverness, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Tallahassee, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Alpharetta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Decatur, Georgia, United States
Research Site
Lawrenceville, Georgia, United States
Research Site
Lithia Springs, Georgia, United States
Research Site
Lovejoy, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Hagerstown, Maryland, United States
Research Site
Lanham, Maryland, United States
Research Site
Largo, Maryland, United States
Research Site
Towson, Maryland, United States
Research Site
Flint, Michigan, United States
Research Site
Kansas City, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Skillman, New Jersey, United States
Research Site
New York, New York, United States
Research Site
North Syracuse, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Greenville, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Portland, Oregon, United States
Research Site
Blue Bell, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Arlington, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
Plano, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Waco, Texas, United States
Research Site
Emporia, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Virginia Beach, Virginia, United States
Research Site
Milwaukee, Wisconsin, United States
Related Publications (1)
Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
PMID: 22329608DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Ubaldo Martin, MD
AstraZeneca
- STUDY DIRECTOR
Tomas LG Andersson
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 20, 2008
Study Start
June 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
November 9, 2012
Results First Posted
November 9, 2012
Record last verified: 2012-10