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Recruiting
NCT05623059
Evaluate Pharmacokinetics and Safety of Slow Release DHEA
Conditions: Asthma, Genotype
Sex: All
Ages: 18 Years – 50 Years
Phase: PHASE1, PHASE2
Enrollment: 9
Sponsor: Indiana University
Location: United States
Summary
This is a study to look at pharmacokinetic levels of different doses of slow release DHEA in subjects with severe asthma.
Eligibility Criteria
Inclusion Criteria:Adult male or female aged between 18 and 50 at time of enrollmentEvidence of asthma demonstrated by either bronchodilator reversibility or methacholine responsiveness either during the run-in or by historical evidence of either criterion if testing was performed under either the 2017 ERS technical standard or the 1999 ATS Guidelines 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: increase in FEV1 less than or equal to 12 percent and 200 ml after up to 8 puffs of albuterol; positive methacholine defined as PC20 greater than or equal to 16mg/ml, or PD20 greater than or equal to 400 mcg; documented physician diagnosis of severe 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; baseline DHEA-S concentration < 45 μg/dL in females and < 90 μg/dL in males; genotype testing positive for either HSD3B1 AA or AC specific variantExclusion Criteria:Pregnant or actively trying to become pregnant; breastfeedingpositive urine pregnancy testKnown lung disease other than asthmaAcute (non asthma-related) dyspnea, viral respiratory illness or asthma exacerbation within 4 weeks of screeningSystemic glucocorticoid dosing for maintenance >10 mg/day of prednisone or equivalentPatients 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 diabetesPatients with any known previous adverse reaction to DHEACurrent 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 weeksUse of any performance-enhancing drugs in the last 2 weeksUse of DHEA in the last 2 weeksAndrogen use for any reasonHSD3B1 CC phenotypeAny 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 PIMenopausal amenorrhea by historyPositive PSA (>4 ng/ml) (Prostate Specific Antigen)Patients on biologic treatments for asthmaPrior diagnosis of vocal cord dysfunction, bronchopulmonary dysplasia, cystic fibrosis, chronic obstructive pulmonary disorder, or other lung diseaseSystolic blood pressure > 150 mm Hg and/or diastolic blood pressure >90 mm HgHeart rates outside the range of 50 to 120 beats per minutes or with a pathologic irregularityPatients 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.
Source: ClinicalTrials.gov (NCT05623059). StuddyBuddy aggregates publicly available trial information.