Evaluate Pharmacokinetics and Safety of Slow Release DHEA

Korábbi kezelés

• 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

Más betegség

• 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

Életkor

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

Egyéb

• 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
• HSD3B1 CC phenotype
• Menopausal amenorrhea by history
• Positive PSA (>4 ng/ml) (Prostate Specific Antigen)
• 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 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