Slow Release DHEA for Asthma (DHEA Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from administration of the first dose to 12 hours after the final dose (up to 59 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how a slow-release form of DHEA behaves in people with severe asthma who have certain genetic markers. The goal is to see if these patients process the hormone differently, which could affect how it should be dosed.

Who is the study for?

Adults aged 18-50 with severe asthma, demonstrated by specific tests or a physician's diagnosis according to NHLBI guidelines. Participants must be non-smokers, not pregnant or lactating, and have been on consistent asthma medication for the past two months. They should have low baseline DHEA-S levels and test positive for certain genetic variants.

What is being tested?

The trial is testing how different doses of slow release DHEA are processed in the body (pharmacokinetics) in subjects with severe asthma. The goal is to understand how this treatment affects individuals with specific genotypes.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions typical of hormone therapies such as changes in mood, acne, hair growth changes, and other hormonal imbalances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 12 hours after the final dose (up to 66 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 12 hours after the final dose (up to 66 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 hours after the final dose (up to 66 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the maximum tolerated dose for slow release DHEA for asthmatic subjects on a regimen of 50mg and 100mg by adverse event evaluation.

Determine the maximum tolerated dose for slow release DHEA in asthmatic subjects on a single and recurring regimen of 50mg and of 100mg by pharmacokinetic evaluation.

Secondary study objectives

Safety and tolerability evaluation measured by a change in physical symptoms from baseline to post-treatment. Physical symptoms will include reports such as cough, shortness of breath, chest tightness, wheeze)

Safety and tolerability evaluation measured by the change in FEV from baseline to post-treatment (as measured by spirometry).

Safety and tolerability evaluation measured by the change in physical exam findings from baseline to post-treatment

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 50mg doseExperimental Treatment1 Intervention

This arm will start with a one-time dose and progress to twice daily dosing for 3 days, every 12 hours. Study cohort will be 9 subjects with asthma. DHEA dose will be 50 mg via slow release capsules. Endpoints will be serum DHEA and DHEA-S levels at 10, 20, 30, 60 min \& 2, 4, 6, 8, 12h after administration. After a one-week washout period, the protocol will be repeated using 100 mg of SR-DHEA.

Group II: 100mg doseExperimental Treatment1 Intervention

This arm will start with a one-time 100mg dose and progress to twice daily dosing for 3 days, every 12 hours. Study cohort will be same 9 subjects with asthma. DHEA dose will be 100mg via slow release capsules. Endpoints will be serum DHEA and DHEA-S levels at 10, 20, 30, 60 min \& 2, 4, 6, 8, 12h after administration.

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