N/A
N=362
Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-Ethnicity (SAPPHIRE)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01142947 ↗Enrolled (actual)
362
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Change in Asthma Control Test Score — 3.32 change in composite score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- beclomethasone dipropionate (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Asthma Control Test Score |
3.32 | — |
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 quantify response to ICS therapy in African American and white patients, as well as look for genetic markers that predict treatment response.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01142947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.