Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA )

Prior treatment

• Patients with any known previous adverse reaction to DHEA
• Use of any performance-enhancing drugs in the last 2 weeks
• Prior diagnosis of vocal cord dysfunction, bronchopulmonary dysplasia, cystic fibrosis, chronic obstructive pulmonary disorder, or other lung disease

Other illness

• Known lung disease other than asthma
• Acute (non-asthma related) dyspnea, viral respiratory illness or asthma exacerbation within 4 weeks of screening
• 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
• 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
• Heart rates outside the range of 50 to 120 beats per minutes or with a pathologic irregularity

Age

• Current smoker or pack year history \> 5 years (includes vaping/nicotine inhalation devices)

Other

• Pregnant or actively trying to become pregnant; breastfeeding
• Positive urine pregnancy test
• Systemic glucocorticoid dosing for maintenance \>10 mg/day of prednisone or equivalent
• Positive urine cotinine test (\> 100 mg/mL)
• Use of prednisone or antibiotics in the last 4 weeks
• Use of DHEA in the last 2 weeks
• Androgen use for any reason.
• Menopausal amenorrhea by history
• Positive Prostate-Specific Antigen (PSA) (\>4 ng/ml) test
• Systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \>90 mm Hg
• 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.

• 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