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

Asthma Clinical Trial

— SAPPHIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142947
• Other study ID #: AI079139
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: March 11, 2019

Study information

• Verified date: March 2019
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 function, diminished symptoms, and fewer exacerbations. However studies show considerable inter-subject variability in ICS response. It has also been estimated that corticosteroid resistance accounts for half of all asthma-related health care costs. Therefore, identifying factors associated with ICS response is both clinical and economically important. African-American patients have been understudied with respect to genetic predictors of asthma controller medication response, and to date there have been no sufficiently powered genome-wide association studies of ICS treatment response among African American individuals with asthma. This issue is of particular importance, since African-American individuals are disproportionately affected by asthma-related complications. In this proposal, we seek to identify novel genetic loci associated with ICS treatment responsiveness (defined by the change in Asthma Control Test score) among African American individuals treated with beclomethasone dipropionate (BD) for 6 weeks. We will attempt to validate loci identified in the discovery set by 1) reassessing these variants for their interaction with ICS treatment on asthma exacerbations in a separate group of African American individuals with asthma, and 2) by reexamining the genetic association with change in asthma control among similarly treated (i.e., treatment with 6 weeks of BD) European Americans with asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: March 11, 2019
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 56 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• beclomethasone dipropionate
160 mcg twice a day (320 mcg per day total)

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Levin AM, Gui H, Hernandez-Pacheco N, Yang M, Xiao S, Yang JJ, Hochstadt S, Barczak AJ, Eckalbar WL, Rynkowski D, Samedy LA, Kwok PY, Pino-Yanes M, Erle DJ, Lanfear DE, Burchard EG, Williams LK. Integrative approach identifies corticosteroid response vari — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Asthma Control Test Score	Patients will be treated with 6 weeks of inhaled beclomethasone diproprionate (BD) treatment and the change in Asthma Control Test (ACT) quantified. The composite ACT score measured at each time point ranged from 5-25 (with higher scores reflective of better asthma control). Therefore, the absolute change in ACT score from before to after treatment could range from -20 to +20.	6 weeks