AsthmaPhase 1/2DHEANCT05623059

Evaluate Pharmacokinetics and Safety of Slow Release DHEA

A Phase 1/2 study testing Slow Release DHEA in people with Asthma and Genotype, run by Indiana University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a study to look at pharmacokinetic levels of different doses of slow release DHEA in subjects with asthma. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Asthma, Genotype
What is being tested?: Slow Release DHEA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 2 sitesUnited States
Study dates: 3 Mar 2023to 24 Apr 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;

Show all 10Show fewer

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

Who cannot join

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.)

Show all 22Show fewer

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
HSD3B1 CC phenotype
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
Menopausal amenorrhea by history
Positive PSA (>4 ng/ml) (Prostate Specific Antigen)
Prior diagnosis of vocal cord dysfunction, bronchopulmonary dysplasia, cystic fibrosis, chronic obstructive pulmonary disorder, or other lung disease
Systolic blood pressure > 150 mm Hg and/or diastolic blood pressure >90 mm Hg
Heart rates outside the range of 50 to 120 beats per minutes or with a pathologic irregularity
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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Riley Hospital for Children
Indianapolis, Indiana, 46202
University Hospital
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Phase IIa Clinical Trial to Evaluate Pharmacokinetics and Safety of Slow Release DHEA

This is a study to look at pharmacokinetic levels of different doses of slow release DHEA in subjects with asthma.

Read the detailed description

Pharmacokinetic (PK) studies of DHEA in asthma have never been done. In many diseases, PK in subjects with disease differs from that of control subjects and those with other conditions. Therefore, researchers are investigating if PK levels of slow release DHEA are different in subjects with asthma who have the HSD3B1 AA or AC phenotypes

Conditions: Asthma, Genotype
Being tested: Slow Release DHEA
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Slow Release DHEADrug
Also called Slow Release Dehydroepiandrosterone
DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.

Study groups in NCT05623059
Study group	Role	What they receive
Slow Release DHEA	Other	This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. 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. Receives: Drug: Slow Release DHEA

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Peak DHEA Concentration ≥100ng/mL or < 100ng/mL at Any Time Point During Single or Multiple Dose Treatments.
The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by measuring the presence in and difference of pharmacokinetics of DHEA in the blood at two dose levels (50mg and 100mg).
Measured: Outcome measure assessed at 50mg Single Dose Visit (Day 14), 100mg Single Dose Visit (Day 22), 50mg Multiple Dose Treatment (Days 30-32), 100mg Multiple Dose Treatment (Days 40-42)
Number of Participants With a Significant, Sustained Increase in DHEA-S in Blood Levels and Without a Significant, Sustained Increased in DHEA-S in Blood Levels for More Than 24hrs, During Multiple Dose Treatments.
The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by measuring the presence in and difference of pharmacokinetics of DHEA-S in the blood at two dose levels (50mg and 100mg).
Measured: Outcome measure assessed every 24 hours during 50mg Multiple Dose Treatment (Days 30-32) and every 24 hours during 100mg Multiple Dose Treatment (Days 40-42)
Number of Participants With Adverse Events (AEs) Related to Study, Unlikely Related to Study, or no AEs at All, at Any Time Point During Single Dose Periods, Multiple Dose Periods, or Washout Periods.
The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by evaluating the occurrences and severity of adverse events during or after dosing at two levels (5omg and 100mg).
Measured: From administration of the first dose to 12 hours after the final dose (up to 59 days)

Secondary outcomes (4)

Number of Participants With Significant Change in Vital Sign Measurement and no Significant Change in Vital Sign Measurements After 50mg Single Dose and After 100mg Single Dose.
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma by measuring the change in vital signs from before 50mg single dose treatment to after 50mg single dose treatment and from beginning of 100mg dose treatment to after 100mg dose treatment.
Measured: Outcome measure assessed at 50mg Single Dose Visit (Day 14) and 100mg Single Dose Visit (Day 22).
Number of Participants With Significant Change in Asthmatic Symptoms, or no Significant Change in Asthmatic Symptoms, After 50mg Multiple Dose and 100mg Multiple Dose.
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma by measuring the change in physical symptoms from before treatment to after treatment. Physical symptoms will include reports such as cough, shortness of breath, chest tightness, wheeze, as measured by symptom diary record.
Measured: Outcome measure assessed at 50mg Multiple Dose Treatment (Day 30), 100mg Multiple Dose Treatment (Day 40)
Number of Participants With a Decrease in FEV1, an Increase in FEV1, and no Change in FEV1, After 50mg Multiple Dose Treatments and 100mg Multiple Dose Treatments.
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma patients by performing pulmonary function testing to obtain measurements of FEV (forced expiratory volume) before treatment and after treatment. All subjects completed the treatment, but not all subjects participated in the pulmonary function testing.
Measured: Outcome measure assessed from beginning to end of 50mg Multiple Dose Treatment (Days 30-32), and beginning to end of 100mg Multiple Dose Treatment (Days 40-42)
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma patients by recording any instance of asthma exacerbation event during or after treatment.
Measured: Outcome measure assessed at 50mg Single Dose Visit (Day 14), 100mg Single Dose Visit (Day 22), 50mg Multiple Dose Treatment (Days 30-32), 100mg Multiple Dose Treatment (Days 40-42).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 202324 Apr 2025

First posted21 Nov 2022
Study start3 Mar 2023
Primary completion24 Apr 2025
Study completion24 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (25)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: This is an unblinded pharmacokinetic (PK) study to determine optimal dosing for future studies. This study 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.
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05623059
Sponsor's protocol ID: 15038
Other IDs: P01HL158507
Acronym: DHEA
Status last verified: Aug 2026
First submitted: 14 Nov 2022
Last updated: 2 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Sadatsafavi M, Lynd L, Marra C, Carleton B, Tan WC, Sullivan S, Fitzgerald JM. Direct health care costs associated with asthma in British Columbia. Can Respir J. 2010 Mar-Apr;17(2):74-80. doi: 10.1155/2010/361071.
PubMed 20422063
Han MK, Arteaga-Solis E, Blenis J, Bourjeily G, Clegg DJ, DeMeo D, Duffy J, Gaston B, Heller NM, Hemnes A, Henske EP, Jain R, Lahm T, Lancaster LH, Lee J, Legato MJ, McKee S, Mehra R, Morris A, Prakash YS, Stampfli MR, Gopal-Srivastava R, Laposky AD, Punturieri A, Reineck L, Tigno X, Clayton J. Female Sex and Gender in Lung/Sleep Health and Disease. Increased Understanding of Basic Biological, Pathophysiological, and Behavioral Mechanisms Leading to Better Health for Female Patients with Lung Disease. Am J Respir Crit Care Med. 2018 Oct 1;198(7):850-858. doi: 10.1164/rccm.201801-0168WS.
PubMed 29746147
Zein JG, Erzurum SC. Asthma is Different in Women. Curr Allergy Asthma Rep. 2015 Jun;15(6):28. doi: 10.1007/s11882-015-0528-y.
PubMed 26141573
Zein J, Gaston B, Bazeley P, DeBoer MD, Igo RP Jr, Bleecker ER, Meyers D, Comhair S, Marozkina NV, Cotton C, Patel M, Alyamani M, Xu W, Busse WW, Calhoun WJ, Ortega V, Hawkins GA, Castro M, Chung KF, Fahy JV, Fitzpatrick AM, Israel E, Jarjour NN, Levy B, Mauger DT, Moore WC, Noel P, Peters SP, Teague WG, Wenzel SE, Erzurum SC, Sharifi N. HSD3B1 genotype identifies glucocorticoid responsiveness in severe asthma. Proc Natl Acad Sci U S A. 2020 Jan 28;117(4):2187-2193. doi: 10.1073/pnas.1918819117. Epub 2020 Jan 13.
PubMed 31932420
Marozkina N, Zein J, DeBoer MD, Logan L, Veri L, Ross K, Gaston B. Dehydroepiandrosterone Supplementation May Benefit Women with Asthma Who Have Low Androgen Levels: A Pilot Study. Pulm Ther. 2019 Dec;5(2):213-220. doi: 10.1007/s41030-019-00101-9. Epub 2019 Oct 21.
PubMed 32026412
Lahm T, Albrecht M, Fisher AJ, Selej M, Patel NG, Brown JA, Justice MJ, Brown MB, Van Demark M, Trulock KM, Dieudonne D, Reddy JG, Presson RG, Petrache I. 17beta-Estradiol attenuates hypoxic pulmonary hypertension via estrogen receptor-mediated effects. Am J Respir Crit Care Med. 2012 May 1;185(9):965-80. doi: 10.1164/rccm.201107-1293OC. Epub 2012 Mar 1.
PubMed 22383500
Bentley JK, Hershenson MB. Airway smooth muscle growth in asthma: proliferation, hypertrophy, and migration. Proc Am Thorac Soc. 2008 Jan 1;5(1):89-96. doi: 10.1513/pats.200705-063VS.
PubMed 18094090
Chang KH, Li R, Kuri B, Lotan Y, Roehrborn CG, Liu J, Vessella R, Nelson PS, Kapur P, Guo X, Mirzaei H, Auchus RJ, Sharifi N. A gain-of-function mutation in DHT synthesis in castration-resistant prostate cancer. Cell. 2013 Aug 29;154(5):1074-1084. doi: 10.1016/j.cell.2013.07.029.
PubMed 23993097
Hall SL, Baker T, Lajoie S, Richgels PK, Yang Y, McAlees JW, van Lier A, Wills-Karp M, Sivaprasad U, Acciani TH, LeCras TD, Myers JB, Kovacic MB, Lewkowich IP. IL-17A enhances IL-13 activity by enhancing IL-13-induced signal transducer and activator of transcription 6 activation. J Allergy Clin Immunol. 2017 Feb;139(2):462-471.e14. doi: 10.1016/j.jaci.2016.04.037. Epub 2016 Jun 11.
PubMed 27417023
Bulitta JB, Jiao Y, Drescher SK, Oliver A, Louie A, Moya B, Tao X, Wittau M, Tsuji BT, Zavascki AP, Shin BS, Drusano GL, Sorgel F, Landersdorfer CB. Four Decades of beta-Lactam Antibiotic Pharmacokinetics in Cystic Fibrosis. Clin Pharmacokinet. 2019 Feb;58(2):143-156. doi: 10.1007/s40262-018-0678-x.
PubMed 29936678
Hettel D, Zhang A, Alyamani M, Berk M, Sharifi N. AR Signaling in Prostate Cancer Regulates a Feed-Forward Mechanism of Androgen Synthesis by Way of HSD3B1 Upregulation. Endocrinology. 2018 Aug 1;159(8):2884-2890. doi: 10.1210/en.2018-00283.
PubMed 29850791
Gaston B, Reilly J, Drazen JM, Fackler J, Ramdev P, Arnelle D, Mullins ME, Sugarbaker DJ, Chee C, Singel DJ, Loscalzo J, Stamler JS. Endogenous nitrogen oxides and bronchodilator S-nitrosothiols in human airways. Proc Natl Acad Sci U S A. 1993 Dec 1;90(23):10957-61. doi: 10.1073/pnas.90.23.10957.
PubMed 8248198
Gaston B, Sears S, Woods J, Hunt J, Ponaman M, McMahon T, Stamler JS. Bronchodilator S-nitrosothiol deficiency in asthmatic respiratory failure. Lancet. 1998 May 2;351(9112):1317-9. doi: 10.1016/S0140-6736(97)07485-0.
PubMed 9643794
Hunt JF, Fang K, Malik R, Snyder A, Malhotra N, Platts-Mills TA, Gaston B. Endogenous airway acidification. Implications for asthma pathophysiology. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):694-9. doi: 10.1164/ajrccm.161.3.9911005.
PubMed 10712309
Carraro S, Doherty J, Zaman K, Gainov I, Turner R, Vaughan J, Hunt JF, Marquez J, Gaston B. S-nitrosothiols regulate cell-surface pH buffering by airway epithelial cells during the human immune response to rhinovirus. Am J Physiol Lung Cell Mol Physiol. 2006 May;290(5):L827-32. doi: 10.1152/ajplung.00406.2005.
PubMed 16603595

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIa Clinical Trial to Evaluate Pharmacokinetics and Safety of Slow Release DHEA
ClinicalTrials.gov ID: NCT05623059
Acronym / sponsor ID: DHEA / 15038
Conditions: Asthma, Genotype
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 3 Mar 2023 (actual)
Primary completion: 24 Apr 2025 (actual)
Study completion: 24 Apr 2025 (actual)
First posted: 21 Nov 2022 (actual)
Results: Posted 2 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a study to look at pharmacokinetic levels of different doses of slow release DHEA in subjects with asthma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: This is an unblinded pharmacokinetic (PK) study to determine optimal dosing for future studies. This study 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.

Arm	Type	Receives
Slow Release DHEA	Other	Drug: Slow Release DHEAThis is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (22 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Slow Release DHEAAlso: Slow Release DehydroepiandrosteroneDHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.	Drug	Slow Release DHEA

Primary outcome

Number of Participants With a Peak DHEA Concentration ≥100ng/mL or < 100ng/mL at Any Time Point During Single or Multiple Dose Treatments.
Time frame: Outcome measure assessed at 50mg Single Dose Visit (Day 14), 100mg Single Dose Visit (Day 22), 50mg Multiple Dose Treatment (Days 30-32), 100mg Multiple Dose Treatment (Days 40-42)
The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by measuring the presence in and difference of pharmacokinetics of DHEA in the blood at two dose levels (50mg and 100mg).
Number of Participants With a Significant, Sustained Increase in DHEA-S in Blood Levels and Without a Significant, Sustained Increased in DHEA-S in Blood Levels for More Than 24hrs, During Multiple Dose Treatments.
Time frame: Outcome measure assessed every 24 hours during 50mg Multiple Dose Treatment (Days 30-32) and every 24 hours during 100mg Multiple Dose Treatment (Days 40-42)
The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by measuring the presence in and difference of pharmacokinetics of DHEA-S in the blood at two dose levels (50mg and 100mg).
Number of Participants With Adverse Events (AEs) Related to Study, Unlikely Related to Study, or no AEs at All, at Any Time Point During Single Dose Periods, Multiple Dose Periods, or Washout Periods.
Time frame: From administration of the first dose to 12 hours after the final dose (up to 59 days)
The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by evaluating the occurrences and severity of adverse events during or after dosing at two levels (5omg and 100mg).

4 secondary outcomes

Number of Participants With Significant Change in Vital Sign Measurement and no Significant Change in Vital Sign Measurements After 50mg Single Dose and After 100mg Single Dose.
Time frame: Outcome measure assessed at 50mg Single Dose Visit (Day 14) and 100mg Single Dose Visit (Day 22).
Number of Participants With Significant Change in Asthmatic Symptoms, or no Significant Change in Asthmatic Symptoms, After 50mg Multiple Dose and 100mg Multiple Dose.
Time frame: Outcome measure assessed at 50mg Multiple Dose Treatment (Day 30), 100mg Multiple Dose Treatment (Day 40)
Number of Participants With a Decrease in FEV1, an Increase in FEV1, and no Change in FEV1, After 50mg Multiple Dose Treatments and 100mg Multiple Dose Treatments.
Time frame: Outcome measure assessed from beginning to end of 50mg Multiple Dose Treatment (Days 30-32), and beginning to end of 100mg Multiple Dose Treatment (Days 40-42)
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
Time frame: Outcome measure assessed at 50mg Single Dose Visit (Day 14), 100mg Single Dose Visit (Day 22), 50mg Multiple Dose Treatment (Days 30-32), 100mg Multiple Dose Treatment (Days 40-42).

Results and safety

Results posted to the registry on 2 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Slow Release DHEA	9	9

Primary outcome: Number of Participants With a Peak DHEA Concentration ≥100ng/mL or < 100ng/mL at Any Time Point During Single or Multiple Dose Treatments.

Time frame: Outcome measure assessed at 50mg Single Dose Visit (Day 14), 100mg Single Dose Visit (Day 22), 50mg Multiple Dose Treatment (Days 30-32), 100mg Multiple Dose Treatment (Days 40-42). Number. Unit: participants

Measure	Slow Release DHEA n = 9
Subjects with a peak DHEA concentration ≥100 ng/mL at any timepoint during single dose visit	1
Subjects with a peak DHEA concentration < 100 ng/mL at any timepoint during single dose visit	8
Subjects with a peak DHEA concentration ≥100 ng/mL at any timepoint during multiple dose treatment	1
Subjects with a peak DHEA concentration < 100 ng/mL at any timepoint during multiple dose treatment	8

Primary outcome: Number of Participants With a Significant, Sustained Increase in DHEA-S in Blood Levels and Without a Significant, Sustained Increased in DHEA-S in Blood Levels for More Than 24hrs, During Multiple Dose Treatments.

Time frame: Outcome measure assessed every 24 hours during 50mg Multiple Dose Treatment (Days 30-32) and every 24 hours during 100mg Multiple Dose Treatment (Days 40-42). Count of participants. Unit: Participants

Measure	Slow Release DHEA n = 9
Participants with significant, sustained increase blood DHEA-S for > 24hr, 50mg multiple dose	9
Participants without significant, sustained increase blood DHEA-S for > 24hr, 50mg multiple dose	0
Participants with significant, sustained increase blood DHEA-S for > 24hr, 100mg multiple dose	9
Participants without significant, sustained increase blood DHEA-S for > 24hr, 100mg multiple dose	0

Primary outcome: Number of Participants With Adverse Events (AEs) Related to Study, Unlikely Related to Study, or no AEs at All, at Any Time Point During Single Dose Periods, Multiple Dose Periods, or Washout Periods.

Time frame: From administration of the first dose to 12 hours after the final dose (up to 59 days). Count of participants. Unit: Participants

Measure	Slow Release DHEA n = 9
Related to study	0
Unlikely or non-related	0
No AEs	9

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From consent until two weeks after final visit, up to 19 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Slow Release DHEA - 50mg Single Dose	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Slow Release DHEA - 100mg Single Dose	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
Slow Release DHEA - 50mg Multiple Dose	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Slow Release DHEA - 100mg Multiple Dose	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20422063Sadatsafavi M, Lynd L, Marra C, Carleton B, Tan WC, Sullivan S, Fitzgerald JM. Direct health care costs associated with asthma in British Columbia. Can Respir J. 2010 Mar-Apr;17(2):74-80. doi: 10.1155/2010/361071.
Background: PubMed 29746147Han MK, Arteaga-Solis E, Blenis J, Bourjeily G, Clegg DJ, DeMeo D, Duffy J, Gaston B, Heller NM, Hemnes A, Henske EP, Jain R, Lahm T, Lancaster LH, Lee J, Legato MJ, McKee S, Mehra R, Morris A, Prakash YS, Stampfli MR, Gopal-Srivastava R, Laposky AD, Punturieri A, Reineck L, Tigno X, Clayton J. Female Sex and Gender in Lung/Sleep Health and Disease. Increased Understanding of Basic Biological, Pathophysiological, and Behavioral Mechanisms Leading to Better Health for Female Patients with Lung Disease. Am J Respir Crit Care Med. 2018 Oct 1;198(7):850-858. doi: 10.1164/rccm.201801-0168WS.
Background: PubMed 26141573Zein JG, Erzurum SC. Asthma is Different in Women. Curr Allergy Asthma Rep. 2015 Jun;15(6):28. doi: 10.1007/s11882-015-0528-y.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Slow Release DHEA in people with Asthma and Genotype, run by Indiana University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Peak DHEA Concentration ≥100ng/mL or < 100ng/mL at Any Time Point During Single or Multiple Dose Treatments. (time frame: Outcome measure assessed at 50mg Single Dose Visit (Day 14), 100mg Single Dose Visit (Day 22), 50mg Multiple Dose Treatment (Days 30-32), 100mg Multiple Dose Treatment (Days 40-42)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05623059, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.