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| ID | Type | Description | Link |
|---|---|---|---|
| P01HL158507 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a study to look at pharmacokinetic levels of different doses of slow release DHEA in subjects with asthma.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50mg dose | Other | This arm will start with a one-time dose and progress to twice daily dosing for 3 days, every 12 hours. Study cohort will be 9 subjects with asthma. DHEA dose will be 50 mg via slow release capsules. Endpoints will be serum DHEA and DHEA-S levels at 10, 20, 30, 60 min & 2, 4, 6, 8, 12h after administration. After a one-week washout period, the protocol will be repeated using 100 mg of SR-DHEA. |
|
| 100mg dose | Other | This arm will start with a one-time 100mg dose and progress to twice daily dosing for 3 days, every 12 hours. Study cohort will be same 9 subjects with asthma. DHEA dose will be 100mg via slow release capsules. Endpoints will be serum DHEA and DHEA-S levels at 10, 20, 30, 60 min & 2, 4, 6, 8, 12h after administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slow Release DHEA | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 two dose levels (50mg and 100mg). | From baseline to 12 hours after the final dose (up to 66 days) |
| Determine the maximum tolerated dose for slow release DHEA for asthmatic subjects on a regimen of 50mg and 100mg by adverse event evaluation. | 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). | From administration of the first dose to 12 hours after the final dose (up to 59 days)] |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability evaluation measured by the change in vital signs from baseline to post-treatment (Vital signs will include heart-rate, respiratory rate, RA saturation) | The objective is to evaluate the safety and tolerability of slow release DHEA in asthma by measuring the change in vital signs from before treatment to after treatment. | From baseline to after the first washout period (up to 63 days)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States | ||
| University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20422063 | Background | 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. | |
| 29746147 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2024 | Jun 24, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2026 | May 19, 2026 | 14 | ||
| Jun 22, 2026 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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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.
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| 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) | 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. | From baseline to after the first washout period (up to 63 days)] |
| Safety and tolerability evaluation measured by the change in physical exam findings from baseline to post-treatment | The objective is to evaluate the safety and tolerability of slow release DHEA in asthma by measuring the change in physical exam findings from before treatment to after treatment. | From baseline to after the first washout period (up to 63 days) |
| Safety and tolerability evaluation measured by the change in FEV from baseline to post-treatment (as measured by spirometry). | 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. | From baseline to after the first washout period (up to 63 days) |
| Safety and tolerability evaluation measured by the occurrence of an asthma exacerbation event during and after 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. | From administration of the first dose to 12 hours after the final dose (up to 59 days) |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| 26141573 | Background | 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. |
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| 23993097 | Background | 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. |
| 27417023 | Background | 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. |
| 29936678 | Background | 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. |
| 29850791 | Background | 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. |
| 8248198 | Background | 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. |
| 9643794 | Background | 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. |
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| 28920065 | Background | Al-Tarrah K, Moiemen N, Lord JM. The influence of sex steroid hormones on the response to trauma and burn injury. Burns Trauma. 2017 Sep 14;5:29. doi: 10.1186/s41038-017-0093-9. eCollection 2017. |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |