NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA )

Not Yet RecruitingPhase 2

Sponsor: Indiana University

Conditions: Asthma

Interventions: Slow Release DHEA, Placebo

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Adult male or female age ≥ 18 and ≤ 50 years at the time of enrollment
2. 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:

1. For bronchodilator reversibility: An increase in FEV1 ≥ 10% (24) compared to the baseline (and 200 ml) after up to 8 puffs of albuterol
2. 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
3. Physician diagnosis of asthma according to NHLBI guidelines
4. Consistent use of an Inhaled Corticosteroids (ICS) inhaler for the prior 2 months
5. Non-smoker
6. Females must not be pregnant or breastfeeding
7. Absence of non-allergic comorbidities

Exclusion Criteria:

1. Pregnant or actively trying to become pregnant; breastfeeding
2. Positive urine pregnancy test
3. Known lung disease other than asthma
4. Acute (non-asthma related) dyspnea, viral respiratory illness or asthma exacerbation within 4 weeks of screening
5. Systemic glucocorticoid dosing for maintenance \>10 mg/day of prednisone or equivalent
6. Patients with significant non-allergic comorbidities (e.g. cerebral palsy, heart disease, kidney disease, liver disease, etc.)
7. Patients with any know central or peripheral endocrine abnormality such as precocious puberty or diabetes
8. Patients with any known previous adverse reaction to DHEA
9. Current smoker or pack year history \> 5 years (includes vaping/nicotine inhalation devices)
10. Positive urine cotinine test (\> 100 mg/mL)
11. Use of prednisone or antibiotics in the last 4 weeks
12. Use of any performance-enhancing drugs in the last 2 weeks
13. Use of DHEA in the last 2 weeks
14. Androgen use for any reason.
15. 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
16. Menopausal amenorrhea by history
17. Positive Prostate-Specific Antigen (PSA) (\>4 ng/ml) test
18. Prior diagnosis of vocal cord dysfunction, bronchopulmonary dysplasia, cystic fibrosis, chronic obstructive pulmonary disorder, or other lung disease
19. Systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \>90 mm Hg
20. Heart rates outside the range of 50 to 120 beats per minutes or with a pathologic irregularity
21. 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.