Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA )
NCT ID: NCT07179952
Last Updated: 2025-11-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-12-30
Study Completion Date
2028-09-30
Brief Summary
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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.
In this study, the investigators want to test and evaluate the safety of DHEA-based treatment.
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Detailed Description
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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.
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
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Asthma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
placebo controlled crossover design
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Pharmacy will maintain mask
Study Groups
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Slow Release DHEA
Subjects will take active capsule 1/day for 4 weeks
Group Type
ACTIVE_COMPARATOR
Slow Release DHEA
Intervention Type
DRUG
Slow-release dehydroepiandrosterone capsule
Placebo
Subjects will take placebo capsule 1/day for 4 weeks
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
placebo capsule
Interventions
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Slow Release DHEA
Slow-release dehydroepiandrosterone capsule
Intervention Type
DRUG
Placebo
placebo capsule
Intervention Type
DRUG
Other Intervention Names
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dehydroepiandrosterone
Eligibility Criteria
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Inclusion Criteria
1. Adult male or female age ≥ 18 and ≤ 50 years at the time of enrollment
2. 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:
1. For bronchodilator reversibility: An increase in FEV1 ≥ 10% (24) compared to the baseline (and 200 ml) after up to 8 puffs of albuterol
2. 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
3. Physician diagnosis of asthma according to NHLBI guidelines
4. Consistent use of an Inhaled Corticosteroids (ICS) inhaler for the prior 2 months
5. Non-smoker
6. Females must not be pregnant or breastfeeding
7. Absence of non-allergic comorbidities
2. 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:
1. For bronchodilator reversibility: An increase in FEV1 ≥ 10% (24) compared to the baseline (and 200 ml) after up to 8 puffs of albuterol
2. 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
3. Physician diagnosis of asthma according to NHLBI guidelines
4. Consistent use of an Inhaled Corticosteroids (ICS) inhaler for the prior 2 months
5. Non-smoker
6. Females must not be pregnant or breastfeeding
7. Absence of non-allergic comorbidities
Exclusion Criteria
1. Pregnant or actively trying to become pregnant; breastfeeding
2. Positive urine pregnancy test
3. Known lung disease other than asthma
4. Acute (non-asthma related) dyspnea, viral respiratory illness or asthma exacerbation within 4 weeks of screening
5. Systemic glucocorticoid dosing for maintenance \>10 mg/day of prednisone or equivalent
6. Patients with significant non-allergic comorbidities (e.g. cerebral palsy, heart disease, kidney disease, liver disease, etc.)
7. Patients with any know central or peripheral endocrine abnormality such as precocious puberty or diabetes
8. Patients with any known previous adverse reaction to DHEA
9. Current smoker or pack year history \> 5 years (includes vaping/nicotine inhalation devices)
10. Positive urine cotinine test (\> 100 mg/mL)
11. Use of prednisone or antibiotics in the last 4 weeks
12. Use of any performance-enhancing drugs in the last 2 weeks
13. Use of DHEA in the last 2 weeks
14. Androgen use for any reason.
15. 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
16. Menopausal amenorrhea by history
17. Positive Prostate-Specific Antigen (PSA) (\>4 ng/ml) test
18. Prior diagnosis of vocal cord dysfunction, bronchopulmonary dysplasia, cystic fibrosis, chronic obstructive pulmonary disorder, or other lung disease
19. Systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \>90 mm Hg
20. Heart rates outside the range of 50 to 120 beats per minutes or with a pathologic irregularity
21. 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.
2. Positive urine pregnancy test
3. Known lung disease other than asthma
4. Acute (non-asthma related) dyspnea, viral respiratory illness or asthma exacerbation within 4 weeks of screening
5. Systemic glucocorticoid dosing for maintenance \>10 mg/day of prednisone or equivalent
6. Patients with significant non-allergic comorbidities (e.g. cerebral palsy, heart disease, kidney disease, liver disease, etc.)
7. Patients with any know central or peripheral endocrine abnormality such as precocious puberty or diabetes
8. Patients with any known previous adverse reaction to DHEA
9. Current smoker or pack year history \> 5 years (includes vaping/nicotine inhalation devices)
10. Positive urine cotinine test (\> 100 mg/mL)
11. Use of prednisone or antibiotics in the last 4 weeks
12. Use of any performance-enhancing drugs in the last 2 weeks
13. Use of DHEA in the last 2 weeks
14. Androgen use for any reason.
15. 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
16. Menopausal amenorrhea by history
17. Positive Prostate-Specific Antigen (PSA) (\>4 ng/ml) test
18. Prior diagnosis of vocal cord dysfunction, bronchopulmonary dysplasia, cystic fibrosis, chronic obstructive pulmonary disorder, or other lung disease
19. Systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \>90 mm Hg
20. Heart rates outside the range of 50 to 120 beats per minutes or with a pathologic irregularity
21. 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
Indiana University
OTHER
Sponsor Role
lead
Responsible Party
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Kirsten Kloepfer
Professor of Pediatrics
Responsibility Role
PRINCIPAL_INVESTIGATOR
Central Contacts
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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26427
Identifier Type: -
Identifier Source: org_study_id
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PHASE1
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.
NCT05763121
TERMINATED
PHASE3
Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma
NCT00530062
COMPLETED
PHASE4
A Multi-dose Study on the Safety and Efficacy of Self-administered Intranasal AD17002 Treatment for Eosinophilic Asthma
NCT07250594
NOT_YET_RECRUITING
PHASE2
Oral Prednisolone Dosing in Children Hospitalized With Asthma
NCT00257933
COMPLETED
PHASE4
Dietary Supplementation With Soy Isoflavones in Asthma
NCT00277446
COMPLETED
NA
(CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)
NCT00394329
COMPLETED
PHASE3
A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid
NCT05292586
COMPLETED
PHASE3
A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects
NCT03622112
COMPLETED
PHASE2
A Study to Investigate the Pharmacokinetics and Safety of Beclomethasone Dipropionate Administered by Breath-Actuated Inhaler and Metered-Dose Inhaler in Healthy Adults
NCT02030457
COMPLETED
PHASE1
Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
NCT02513160
COMPLETED
PHASE3
A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler)
NCT01056159
COMPLETED
PHASE1
A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
NCT00624429
UNKNOWN
PHASE4
Study Evaluating Etanercept in Moderate to Severe Asthma
NCT00141791
COMPLETED
PHASE2
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
NCT02040766
COMPLETED
PHASE3
Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
NCT07326995
RECRUITING
PHASE2
Recombinant Human IL-4 Receptor Used in Treatment of Asthma
NCT00017693
COMPLETED
PHASE2
Intravenous Terbutaline in Severe Status Asthmaticus
NCT00750568
UNKNOWN
Study of Inhaled Glucocorticosteroid Administration in Asthma Patients
NCT00559689
COMPLETED