Not Yet RecruitingPhase 2

Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA )

30 participantsStarted 2027-01-01

Plain-language summary

There is evidence to suggest that DHEA-based treatment could be beneficial to patients with asthma, yet one of the main treatments for asthma (taking glucocorticoids, a hormone that is effective in reducing inflammation), suppresses the production of DHEA. In this study, the investigators want to test and evaluate the safety of DHEA-based treatment.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult male or female age ≥ 18 and ≤ 50 years at the time of enrollment
✓. Evidence of asthma demonstrated by reversibility at visit 0 or by historical methacholine or bronchodilator reversibility if testing was performed under either the 2017 European Respiratory Society (ERS) technical standard (22) or the 1999 American Thoracis Society (ATS) Guidelines (23) or outside studies, provided that full sets of flow volume loops have been reviewed and approved by the PI. These criteria are defined as one of the following:
✓. For bronchodilator reversibility: An increase in FEV1 ≥ 10% (24) compared to the baseline (and 200 ml) after up to 8 puffs of albuterol
✓. For historical methacholine responsiveness: Positive methacholine defined as Provocative Concentration of Methacholine causing a 20% fall in FEV1 (PC20) ≤ 16 mg/ml, or Provocative Dose of Methacholine causing a 20% fall in FEV1 (PD20) ≤ 400 mcg
✓. Physician diagnosis of asthma according to NHLBI guidelines
✓. Consistent use of an Inhaled Corticosteroids (ICS) inhaler for the prior 2 months
✓. Non-smoker
✓. Females must not be pregnant or breastfeeding

Exclusion criteria

✕. Pregnant or actively trying to become pregnant; breastfeeding
✕. Positive urine pregnancy test
✕. Known lung disease other than asthma
✕. Acute (non-asthma related) dyspnea, viral respiratory illness or asthma exacerbation within 4 weeks of screening
✕. Systemic glucocorticoid dosing for maintenance \>10 mg/day of prednisone or equivalent
✕. Patients with significant non-allergic comorbidities (e.g. cerebral palsy, heart disease, kidney disease, liver disease, etc.)
✕. Patients with any know central or peripheral endocrine abnormality such as precocious puberty or diabetes
✕. Patients with any known previous adverse reaction to DHEA

What they're measuring

Scores of Asthma Control Test

Timeframe: From baseline to 12 hours after the final dose of final arm (up to 94 days)

Scores of Asthma Control Questionnaire

Timeframe: From baseline to 12 hours after the final dose of final arm (up to 94 days)

Trial details

NCT IDNCT07179952

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-30

Contact for this trial

Fanmuyi Yang, PhD

3172748895 fy5@iu.edu

View on ClinicalTrials.gov More Asthma trials