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Hormone Therapy
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
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)
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 moreSide effects data
From 2015 Phase 3 trial • 558 Patients • NCT020135446%
Application site discharge
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.50% Prasterone (DHEA)
Placebo
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 severe asthma and serum DHEA-S \<90 μg/dL in men and \<45 μg/dL in women. 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 severe asthma and serum DHEA-S \<90 μg/dL in men and \<45 μg/dL in women. 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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Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,114,188 Total Patients Enrolled
17 Trials studying Asthma
4,735 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,180 Total Patients Enrolled
280 Trials studying Asthma
114,161 Patients Enrolled for Asthma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stopped having periods due to menopause.I am currently using androgens for any reason.I have been diagnosed with a specific lung disease before.I have not used DHEA in the last 2 weeks.My genetic test shows I have the HSD3B1 CC variant.I currently smoke or have a history of smoking more than 5 pack-years.I have been using an ICS/LABA inhaler regularly for the last 2 months.I am not pregnant or breastfeeding.I have a lung condition that is not asthma.I haven't had severe shortness of breath or a viral lung infection in the last 4 weeks.I am between 18 and 50 years old.My genetic test shows I have the HSD3B1 AA or AC variant.I have not taken prednisone or antibiotics in the last 4 weeks.My asthma diagnosis was confirmed with specific breathing tests.I am receiving biologic treatments for my asthma.My heart rate is between 50 and 120 bpm and regular.My DHEA-S levels are below the normal range for my gender.I have a diagnosed hormone gland disorder.I take more than 10 mg/day of prednisone or its equivalent for my condition.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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