Can a hormone supplement tame asthma?
NCT ID NCT05623059
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
Researchers are testing whether slow release DHEA, a hormone supplement, is safe and well tolerated in adults with asthma. The trial gives two dose levels, 50 mg and 100 mg, and measures how the hormone builds up in the blood and clears from the body. Participants are adults aged 18 to 50 with asthma and a specific genetic profile. The goal is to find the highest dose that people can take without serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Slow release dehydroepiandrosterone (DHEA), a hormone supplement
- What this could lead to
- If it works, this could point toward a new way to manage asthma symptoms using a hormone supplement.
- What could go wrong
- This is an early safety and dosing trial with only 18 participants, so it may not show clear benefit or apply to everyone with asthma.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
18 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Apr 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult male or female aged between 18 and 50 at 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 ERS technical standard (22) or the 1999 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 PC20 ≤ 16 mg/ml, or PD20 ≤400 mcg * Physician diagnosis of asthma according to NHLBI guidelines; * Consistent use of an ICS/LABA inhaler for the prior 2 months; * Non smoker; * Females must not be pregnant or lactating; * Absence of non-allergic comorbidities; * Genotype testing positive for either HSD3B1 AA or AC specific variant 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 * Current smoker or pack year history \> 5 years (includes vaping/nicotine inhalation devices) * Positive urine cotinine test (\> 100 mg/mL) * Use of prednisone or antibiotics in the last 4 weeks * Use of any performance-enhancing drugs in the last 2 weeks * Use of DHEA in the last 2 weeks * Androgen use for any reason * HSD3B1 CC phenotype * Any other condition or finding that would compromise the safety of the subject or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the PI * Menopausal amenorrhea by history * Positive PSA (\>4 ng/ml) (Prostate Specific Antigen) * Prior diagnosis of vocal cord dysfunction, bronchopulmonary dysplasia, cystic fibrosis, chronic obstructive pulmonary disorder, or other lung disease * Systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \>90 mm Hg * Heart rates outside the range of 50 to 120 beats per minutes or with a pathologic irregularity * Patients afflicted with any additional acute or chronic pathology that in the opinion of the screening physician makes them unsuitable for study or increases the risks associated with the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
-
University Hospital
Indianapolis, Indiana, 46202, United States
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