An interventional study of beclomethasone dipropionate in Asthma, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 12 Years to 56 Years. Per ClinicalTrials.gov, last updated 2019-04-02.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Basic science
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.
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.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 362 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
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Exclusion Criteria for Discovery Group:
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.
Drug: beclomethasone dipropionate
160 mcg twice a day (320 mcg per day total)
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.
Time frame: 6 weeks
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.
| Milestone | Beclomethasone Dipropionate (BD) |
|---|---|
| Started | 362 |
| Completed | 244 |
| Not completed | 118 |
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.
| change in composite score | Beclomethasone Dipropionate (BD) |
|---|---|
| Change in Asthma Control Test Score | 3.32 ± 4.47 |
Collected over 6 weeks of treatment with inhaled beclomethasone dipropionate.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Beclomethasone Dipropionate (BD) | 0/362 (0%) | 0/362 (0%) | 0/362 (0%) |
| Age, Continuous(years) | Beclomethasone Dipropionate (BD) |
|---|---|
| Mean | 32.2 ± 13.0 |
| Sex: Female, Male(Participants) | Beclomethasone Dipropionate (BD) |
|---|---|
| Female | 216 |
| Male | 146 |
| Race (NIH/OMB)(Participants) | Beclomethasone Dipropionate (BD) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 362 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Proportion of African Genetic Ancestry(% African Ancestry (within individuals)) | Beclomethasone Dipropionate (BD) |
|---|---|
| Mean | 80.6 ± 8.7 |
| Body Mass Index(kilograms per meters squared) | Beclomethasone Dipropionate (BD) |
|---|---|
| Mean | 32.4 ± 9.5 |
| Smoking Status(Participants) | Beclomethasone Dipropionate (BD) |
|---|---|
| Never Smoker | 315 |
| Past Smoker | 37 |
| Current Smoker | 3 |
| Initial Asthma Control Test Score(Composite Score) | Beclomethasone Dipropionate (BD) |
|---|---|
| Mean | 17.8 ± 5.0 |
| Percent of Predicted Forced Expiratory Volume at 1 Second(% of the predicted FEV1) | Beclomethasone Dipropionate (BD) |
|---|---|
| Mean | 73.0 ± 12.6 |
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The record gives a start of Oct 2007, a primary completion of Feb 2017 and a completion of Mar 2019. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2019, 2 years 2 months after primary completion.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beclomethasone