Status:
NOT_YET_RECRUITING
Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA )
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 re...
Detailed Description
During this study, participants will come to the study site 4-5 times and have 2 telephone visits over a period of approximately 3 months. Participants will complete the following: Informed Consent: ...
Eligibility Criteria
Inclusion
- 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
- Absence of non-allergic comorbidities
Exclusion
- 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.
- 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 Prostate-Specific Antigen (PSA) (\>4 ng/ml) test
- 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.
Key Trial Info
Start Date :
December 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07179952
Start Date
December 30 2025
End Date
September 30 2028
Last Update
November 28 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.