Status:
COMPLETED
Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-Ethnicity (SAPPHIRE)
Lead Sponsor:
Henry Ford Health System
Conditions:
Asthma
Eligibility:
All Genders
12-56 years
Phase:
NA
Brief Summary
Inhaled corticosteroids (ICS) are considered first-line treatment for persistent asthma, yet little is known about the genetic factors that influence response to this therapy. This study seeks to quan...
Detailed Description
Inhaled corticosteroids (ICS) are considered first-line therapy for the management and control of patients with persistent asthma. Use of inhaled steroids has been associated with improved lung functi...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Discovery Group:
- Age 12-56 years
- Physician diagnosis of asthma (identified by using encounter data prior to screening and by the survey administered at the clinic visit)
- Bronchodilator reversibility on pulmonary function testing (i.e., improvement in baseline FEV1 of \>12%)
- African-American/Black self-reported race-ethnicity
- Exclusion Criteria for Discovery Group:
- Smoking in the preceding year or \<10 pack-year smoking history total
- Pregnant at the time of enrollment or intending to get pregnant during the 6-week treatment period
- Oral or inhaled corticosteroid use in the 4 weeks preceding enrollment
- Prior diagnosis of chronic obstructive pulmonary disease or emphysema
- Prior diagnosis of congestive heart failure
- Self-reported race not African-American/Black or Hispanic ethnicity (these groups could be included in Replication/Validation group)
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2019
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT01142947
Start Date
October 1 2007
End Date
March 11 2019
Last Update
April 2 2019
Active Locations (1)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202