Evaluate Pharmacokinetics and Safety of Slow Release DHEA

Completed · Phase 1/Phase 2

Conditions studied: Asthma, Genotype

In brief

This is a study to look at pharmacokinetic levels of different doses of slow release DHEA in subjects with asthma.

Key facts

Study ID

NCT05623059

Run by

Indiana University

People needed

18

Starts

2023-03-03

Expected to finish

2025-04-24

Last updated by the study team

2025-07-10

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Riley Hospital for Children — Indianapolis, Indiana, United States
• University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.