An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
A 12-week, Randomised, Double Blind, Active-controlled, Multi-centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma
1 other identifier
interventional
558
2 countries
39
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 Hispanic population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Jan 2007
39 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
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 5, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
August 27, 2012
CompletedAugust 27, 2012
August 1, 2012
1.4 years
January 5, 2007
May 20, 2009
August 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morning Peak Expiratory Flow (AM PEF)
Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.
Baseline (run-in) and throughout 12 weeks
Secondary Outcomes (15)
Percentage of Participants With Pre-defined Asthma Events
12 weeks
Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"
12 weeks
Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Baseline, 2, 6 and 12 weeks
Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)
Baseline (run-in) and throughout 12 weeks
Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks
Baseline (run-in) and throughout 12 weeks
- +10 more secondary outcomes
Study Arms (2)
Symbicort
ACTIVE COMPARATORSYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Budesonide
ACTIVE COMPARATORbudesonide HFA pMDI 160 μg x 2 actuations twice daily
Interventions
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Eligibility Criteria
You may qualify if:
- Male or Female, Hispanic (self-reported), \> 12 years of age
- Moderate to severe asthma requiring treatment with an inhaled corticosteroid
- Diagnosis of asthma for at least 6 months
You may not qualify if:
- Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
- Any significant disease or disorder that may jeopardize a subject's safety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (39)
Research Site
Anaheim, California, United States
Research Site
Chula Vista, California, United States
Research Site
Fresno, California, United States
Research Site
Fullerton, California, United States
Research Site
Los Angeles, California, United States
Research Site
National City, California, United States
Research Site
Rancho Cordova, California, United States
Research Site
Rancho Mirage, California, United States
Research Site
Riverside, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
Stockton, California, United States
Research Site
Torrance, California, United States
Research Site
Pueblo, Colorado, United States
Research Site
Largo, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Naranja, Florida, United States
Research Site
North Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Panama City, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Newburgh, New York, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Boerne, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Spring, Texas, United States
Research Site
Aguas Buenas, Puerto Rico
Research Site
Caquas, Puerto Rico
Research Site
Cidra, Puerto Rico
Research Site
Levittown, Puerto Rico
Research Site
Ponce, Puerto Rico
Research Site
SanJuan, Puerto Rico
Research Site
Trujillo Alto, Puerto Rico
Related Publications (2)
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: 22329608DERIVEDZangrilli J, Mansfield LE, Uryniak T, O'Brien CD. Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. Ann Allergy Asthma Immunol. 2011 Sep;107(3):258-65.e2. doi: 10.1016/j.anai.2011.05.024. Epub 2011 Jul 14.
PMID: 21875546DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Christer Hultquist, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
January 5, 2007
First Posted
January 9, 2007
Study Start
January 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
August 27, 2012
Results First Posted
August 27, 2012
Record last verified: 2012-08