Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-Ethnicity (SAPPHIRE)

• Status: Completed
• Trial end date: 2019-03-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: Beclomethasone

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)