Trial Outcomes & Findings for Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-Ethnicity (SAPPHIRE) (NCT NCT01142947)
NCT ID: NCT01142947
Last Updated: 2019-04-02
Results Overview
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.
COMPLETED
NA
362 participants
6 weeks
2019-04-02
Participant Flow
362 self-reported African American enrolled in 6-week treatment with inhaled beclomethasone dipropionate; 291 returned at the end of treatment; 262 with measurable medication adherence; 244 with genome-wide genotype data.
Participant milestones
| Measure |
Beclomethasone Dipropionate (BD)
Patients who meet eligibility criteria will be treated with 6 weeks of beclomethasone dipropionate to assess change in asthma control. This change will be the phenotype used in discovery for the genetic association study. There is no placebo group.
beclomethasone dipropionate: 160 mcg twice a day (320 mcg per day total)
|
|---|---|
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Overall Study
STARTED
|
362
|
|
Overall Study
COMPLETED
|
244
|
|
Overall Study
NOT COMPLETED
|
118
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some individuals did not have the genome wide genotype data needed to assess genetic ancestry.
Baseline characteristics by cohort
| Measure |
Beclomethasone Dipropionate (BD)
n=362 Participants
Patients who meet eligibility criteria will be treated with 6 weeks of beclomethasone dipropionate to assess change in pulmonary function and asthma control. These change will be used as phenotypes in a genetic association study. There is no placebo group.
beclomethasone dipropionate: 160 mcg twice a day (320 mcg per day total)
|
|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 13.0 • n=362 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=362 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=362 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=362 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=362 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=362 Participants
|
|
Race (NIH/OMB)
Black or African American
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362 Participants
n=362 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=362 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=362 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=362 Participants
|
|
Proportion of African Genetic Ancestry
|
80.6 % African Ancestry (within individuals)
STANDARD_DEVIATION 8.7 • n=330 Participants • Some individuals did not have the genome wide genotype data needed to assess genetic ancestry.
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|
Body Mass Index
|
32.4 kilograms per meters squared
STANDARD_DEVIATION 9.5 • n=362 Participants
|
|
Smoking Status
Never Smoker
|
315 Participants
n=355 Participants • Smoking status missing on seven individuals
|
|
Smoking Status
Past Smoker
|
37 Participants
n=355 Participants • Smoking status missing on seven individuals
|
|
Smoking Status
Current Smoker
|
3 Participants
n=355 Participants • Smoking status missing on seven individuals
|
|
Initial Asthma Control Test Score
|
17.8 Composite Score
STANDARD_DEVIATION 5.0 • n=354 Participants • Initial ACT score missing in 8 individuals
|
|
Percent of Predicted Forced Expiratory Volume at 1 Second
|
73.0 % of the predicted FEV1
STANDARD_DEVIATION 12.6 • n=362 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPatients 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.
Outcome measures
| Measure |
Beclomethasone Dipropionate (BD)
n=244 Participants
Patients who meet eligibility criteria will be treated with 6 weeks of beclomethasone dipropionate to assess change in pulmonary function and asthma control. These change will be used as phenotypes in a genetic association study. There is no placebo group.
beclomethasone dipropionate: 160 mcg twice a day (320 mcg per day total)
|
|---|---|
|
Change in Asthma Control Test Score
|
3.32 change in composite score
Standard Deviation 4.47
|
Adverse Events
Beclomethasone Dipropionate (BD)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
L. Keoki Williams, MD, MPH
Center for Individualized and Genomic Medicine Research, Henry Ford Health System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place