Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA )

NCT07179952 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: 26427P01HL158507
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Scores of Asthma Control Test

  Determine if slow-release DHEA in patients with asthma improves asthma control based on ACT (Asthma Control Test) scoring. Results will be between 0-25. 20-25: Well-controlled asthma 16-19: Not well-controlled asthma 15 or less: Very poorly-controlled asthma

  From baseline to 12 hours after the final dose of final arm (up to 94 days)

• Scores of Asthma Control Questionnaire

  Determine if slow-release DHEA in patients with asthma improves asthma control based on ACQ (Asthma Control Questionnaire) scoring. Results will be between 0 and \>1.5. Well-controlled asthma is indicated by a score ≤ 0.75 Partly controlled asthma is indicated by a score between 0.75 to \< 1.5 Not well-controlled asthma is indicated by a score ≥ 1.5

  From baseline to 12 hours after the final dose of final arm (up to 94 days)

Secondary Outcomes (3)

• Measurements of Forced Expiratory Volume in 1 Second

  From baseline to 12 hours after the final dose of final arm (up to 94 days)

• Measurements of Fractional Exhaled Nitric Oxide

  From baseline to 12 hours after the final dose of final arm (up to 94 days)

• Incidences of Adverse Events

  From baseline to 12 hours after the final dose of final arm (up to 94 days)

Study Arms (2)

Slow Release DHEA

ACTIVE COMPARATOR

Subjects will take active capsule 1/day for 4 weeks

Drug: Slow Release DHEA

Placebo

PLACEBO COMPARATOR

Subjects will take placebo capsule 1/day for 4 weeks

Drug: Placebo

Interventions

Slow Release DHEA DRUG

Slow-release dehydroepiandrosterone capsule

Also known as: dehydroepiandrosterone

Slow Release DHEA

Placebo DRUG

placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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.
• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Indiana University: lead

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MeSH Terms

Conditions

Asthma

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Central Study Contacts

Fanmuyi Yang, PhD

CONTACT

3172748895; fy5@iu.edu

Kenzie Mahan

CONTACT

3172748899; krmahan@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy will maintain mask
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: placebo controlled crossover design

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 18, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02