AsthmaPhase 2NCT07179952
Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA )
A Phase 2 study testing Slow Release DHEA in people with Asthma, run by Indiana University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Slow Release DHEA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 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
Show all 9Show fewer
- Non-smoker
- Females must not be pregnant or breastfeeding
- Absence of non-allergic comorbidities
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 21Show 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.
- 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 Prostate-Specific Antigen (PSA) (>4 ng/ml) test
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study to Evaluate Efficacy and Safety of Slow Release DHEA
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.
Read the detailed description
During this study, participants will come to the study site 4-5 times and have 2 telephone visits over a period of approximately 3 months. Participants will complete the following:
Informed Consent: Coordinators will explain the study to participants. If participants decide to participate, they will be asked to review, sign, and date the consent form.
Medical History: Coordinators will review participants medical chart and record relevant medical history, including the history of asthma, other pertinent respiratory details, and any information regarding underlying diseases such as cystic fibrosis or chronic lung disease. Coordinators will also ask participants about any medications they are currently taking.
Demographic Information: Coordinators will collect information about participants such as age, gender, and race.
Physical Exam \& Vital Signs: The study doctor will examine the participants head, eyes, ears, nose, throat; heart, chest, lungs, and abdomen; extremities and skin; and any other areas as appropriate for any abnormal signs and symptoms. In addition, they will also check participants vital signs which includes measuring blood pressure, temperature, heart rate, breathing rate, pulse oximetry (the amount of oxygen in the blood), and height and weight.
Urine Samples: All participants will be asked to provide a urine sample that will be tested for cotinine levels (to indicate whether participant has been exposed to nicotine recently).
Pregnancy Testing \& Contraception Females who can get pregnant will also have a pregnancy test. Because DHEA is a hormone and it is not known how it will affect a developing baby, if the participant is pregnant, they cannot be in this study. Additionally, they must practice a medically acceptable form of contraception during study participation. Medically acceptable contraceptives include: (1) surgical sterilization, (2) approved hormonal contraceptives such as birth control pills, (3) barrier methods (such as a condom or diaphragm) used with a spermicide, (4) abstinence, or (5) an intrauterine device (IUD).
Blood Samples: At each in-person visit, the study team will draw up to 40ml (about 8 teaspoons) of the participants blood to assess overall blood health (complete blood count, or CBC), metabolic and organ function (comprehensive metabolic panel), hormone levels, and immune system activity (cytokine responses and peripheral blood mononuclear cells or PBMCs). The study team will also use the participants blood sample for genotyping (studying genetic makeup), their ability to process DHEA; and measuring the level of DHEA-S. For male subjects, a portion will be used for a Prostate Specific Antigen Test, which checks for prostate cancer.
Spirometry: This test measures how much air a persons lungs can hold and how fast they can breathe out. Participants will take a deep breath and then blow into a mouthpiece as hard as possible and for as long as possible. They might have to wear soft nose clips during the test to stop air from escaping through the nose. They will be asked to repeat this test at least 3 times. They will be asked to take a bronchodilator (a medication that relaxes and opens the airways in the lungs) such as albuterol while completing spirometry during some study visits. The study team will provide the bronchodilator used for the test.
Methacholine Challenge Testing (MCT): This test will be done only if the participant failed to demonstrate 10% reversibility in Forced Expiratory Volume in 1 Second (FEV1) and there are no historical MCT results available.
MCT is done to confirm that the participant has asthma. Methacholine is approved by the FDA. When methacholine is inhaled, it causes the airways to spasm (contract involuntarily) and narrow if asthma is present. During this test, the participant will inhale increasing amounts of methacholine aerosol mist before and after spirometry. The MCT is considered positive, meaning asthma is present, if the participants lung function drops by at least 20%.
If the participants airways tighten at any point, they will be given albuterol to open their airways. Often, the staff person doing the test will know that the participants airways are tightening before they feel it, by seeing a drop in the test results. A bronchodilator is always given at the end of the test to reverse the effects of the methacholine.
Completion of Questionnaire \& Symptom Diary: Participants will be asked to complete the Asthma Control Test (ACT) and the Asthma Control Questionnaire (ACQ) at several study visits. They will also be asked to complete a medication dosing and symptom diary at home between visits 1 and 3 and visits 4 and 6.
Randomization: Participants will be randomly assigned (like flipping a coin) to receive either DHEA or placebo.
Study Drug: DHEA is an over-the-counter supplement that is available on the market without prescription. In this study, the participants will be taking DHEA or placebo as a capsule that has been formulated in a specific way that the investigators expect will make it as effective as possible. The participants will be provided enough capsules for the four-week window of administration.
At Visits 3 and 6, the participants will please return all unused DHEA capsules and packaging to the study team.
There is also one unscheduled visit that will be used in case the participant needs to return to the study site for any reason to finish study activities.
- Conditions
- Asthma
- Being tested
- Slow Release DHEA, Placebo
- 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 dehydroepiandrosterone
Slow-release dehydroepiandrosterone capsule
PlaceboDrug
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Slow Release DHEA | Active comparator | Subjects will take active capsule 1/day for 4 weeks Receives: Drug: Slow Release DHEA |
| Placebo | Placebo comparator | Subjects will take placebo capsule 1/day for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
FEV1 (Forced Expiratory Volume in 1 Second) will be measured using spirometry at baseline and every in person visit.
Measured: From baseline to 12 hours after the final dose of final arm (up to 94 days)
Measurements of Fractional Exhaled Nitric Oxide
FeNO (Fractional Exhaled Nitric Oxide) will be measured at baseline and at each in person visit.
Measured: From baseline to 12 hours after the final dose of final arm (up to 94 days)
Incidences of Adverse Events
Adverse Events will be recorded from baseline and at every visit.
Measured: From baseline to 12 hours after the final dose of final arm (up to 94 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jan 2027 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- placebo controlled crossover design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kirsten Kloepfer, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179952
- Sponsor's protocol ID
- 26427
- Other IDs
- P01HL158507
- Status last verified
- Feb 2026
- First submitted
- 6 Aug 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- 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 20422063Han 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 29746147Zein 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 26141573Zein 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 31932420Marozkina 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 32026412Lahm 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 22383500Bentley 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 18094090Chang 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 23993097Hall 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 27417023Bulitta 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 29936678Hettel 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 29850791NICOLL WD, WATSON AJ, WHITELAW JW. Two cases of marrow failure with massive marrow plasmocytosis simulating myelomatosis. J Clin Pathol. 1958 Sep;11(5):377-81. doi: 10.1136/jcp.11.5.377. No abstract available.
PubMed 13575549Hunt 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 10712309Carraro 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 16603595Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12.
PubMed 24337046
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Efficacy and Safety of Slow Release DHEA
- ClinicalTrials.gov ID
- NCT07179952
- Acronym / sponsor ID
- 26427
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During this study, participants will come to the study site 4-5 times and have 2 telephone visits over a period of approximately 3 months. Participants will complete the following:
Informed Consent: Coordinators will explain the study to participants. If participants decide to participate, they will be asked to review, sign, and date the consent form.
Medical History: Coordinators will review participants medical chart and record relevant medical history, including the history of asthma, other pertinent respiratory details, and any information regarding underlying diseases such as cystic fibrosis or chronic lung disease. Coordinators will also ask participants about any medications they are currently taking.
Demographic Information: Coordinators will collect information about participants such as age, gender, and race.
Physical Exam \& Vital Signs: The study doctor will examine the participants head, eyes, ears, nose, throat; heart, chest, lungs, and abdomen; extremities and skin; and any other areas as appropriate for any abnormal signs and symptoms. In addition, they will also check participants vital signs which includes measuring blood pressure, temperature, heart rate, breathing rate, pulse oximetry (the amount of oxygen in the blood), and height and weight.
Urine Samples: All participants will be asked to provide a urine sample that will be tested for cotinine levels (to indicate whether participant has been exposed to nicotine recently).
Pregnancy Testing \& Contraception Females who can get pregnant will also have a pregnancy test. Because DHEA is a hormone and it is not known how it will affect a developing baby, if the participant is pregnant, they cannot be in this study. Additionally, they must practice a medically acceptable form of contraception during study participation. Medically acceptable contraceptives include: (1) surgical sterilization, (2) approved hormonal contraceptives such as birth control pills, (3) barrier methods (such as a condom or diaphragm) used with a spermicide, (4) abstinence, or (5) an intrauterine device (IUD).
Blood Samples: At each in-person visit, the study team will draw up to 40ml (about 8 teaspoons) of the participants blood to assess overall blood health (complete blood count, or CBC), metabolic and organ function (comprehensive metabolic panel), hormone levels, and immune system activity (cytokine responses and peripheral blood mononuclear cells or PBMCs). The study team will also use the participants blood sample for genotyping (studying genetic makeup), their ability to process DHEA; and measuring the level of DHEA-S. For male subjects, a portion will be used for a Prostate Specific Antigen Test, which checks for prostate cancer.
Spirometry: This test measures how much air a persons lungs can hold and how fast they can breathe out. Participants will take a deep breath and then blow into a mouthpiece as hard as possible and for as long as possible. They might have to wear soft nose clips during the test to stop air from escaping through the nose. They will be asked to repeat this test at least 3 times. They will be asked to take a bronchodilator (a medication that relaxes and opens the airways in the lungs) such as albuterol while completing spirometry during some study visits. The study team will provide the bronchodilator used for the test.
Methacholine Challenge Testing (MCT): This test will be done only if the participant failed to demonstrate 10% reversibility in Forced Expiratory Volume in 1 Second (FEV1) and there are no historical MCT results available.
MCT is done to confirm that the participant has asthma. Methacholine is approved by the FDA. When methacholine is inhaled, it causes the airways to spasm (contract involuntarily) and narrow if asthma is present. During this test, the participant will inhale increasing amounts of methacholine aerosol mist before and after spirometry. The MCT is considered positive, meaning asthma is present, if the participants lung function drops by at least 20%.
If the participants airways tighten at any point, they will be given albuterol to open their airways. Often, the staff person doing the test will know that the participants airways are tightening before they feel it, by seeing a drop in the test results. A bronchodilator is always given at the end of the test to reverse the effects of the methacholine.
Completion of Questionnaire \& Symptom Diary: Participants will be asked to complete the Asthma Control Test (ACT) and the Asthma Control Questionnaire (ACQ) at several study visits. They will also be asked to complete a medication dosing and symptom diary at home between visits 1 and 3 and visits 4 and 6.
Randomization: Participants will be randomly assigned (like flipping a coin) to receive either DHEA or placebo.
Study Drug: DHEA is an over-the-counter supplement that is available on the market without prescription. In this study, the participants will be taking DHEA or placebo as a capsule that has been formulated in a specific way that the investigators expect will make it as effective as possible. The participants will be provided enough capsules for the four-week window of administration.
At Visits 3 and 6, the participants will please return all unused DHEA capsules and packaging to the study team.
There is also one unscheduled visit that will be used in case the participant needs to return to the study site for any reason to finish study activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo controlled crossover design
| Arm | Type | Receives |
|---|---|---|
| Slow Release DHEA | Active comparator | Drug: Slow Release DHEASubjects will take active capsule 1/day for 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will take placebo capsule 1/day for 4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- Physician diagnosis of asthma according to NHLBI guidelines
- Consistent use of an Inhaled Corticosteroids (ICS) inhaler for the prior 2 months
- Non-smoker
Key exclusion criteria (21 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: dehydroepiandrosteroneSlow-release dehydroepiandrosterone capsule | Drug | Slow Release DHEA |
| Placeboplacebo capsule | Drug | Placebo |
Primary outcome
Scores of Asthma Control Test
Time frame: From baseline to 12 hours after the final dose of final arm (up to 94 days)
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
Scores of Asthma Control Questionnaire
Time frame: From baseline to 12 hours after the final dose of final arm (up to 94 days)
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
3 secondary outcomes
Measurements of Forced Expiratory Volume in 1 Second
Time frame: From baseline to 12 hours after the final dose of final arm (up to 94 days)
Measurements of Fractional Exhaled Nitric Oxide
Time frame: From baseline to 12 hours after the final dose of final arm (up to 94 days)
Incidences of Adverse Events
Time frame: From baseline to 12 hours after the final dose of final arm (up to 94 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Slow Release DHEA in people with Asthma, run by Indiana University.
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 9 inclusion and 21 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanmuyi Yang, PhD (3172748895, fy5@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of Asthma Control Test (time frame: From baseline to 12 hours after the final dose of final arm (up to 94 days)). The study lists 2 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 NCT07179952, which also lists 29 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 27 Feb 2026.