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H01 in Adults With Interstitial Lung Disease (The SOLIS Study)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 269 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Secondary endpoints: 4 to 5v269
  2. Minor Eligibility criteria expanded, about 103 words
    • Study description expanded, about 23 words
    v268
  3. Minor 2 versions Re-verified since Feb 25, 2026, no change to tracked fieldsv266-v267
  4. Minor Eligibility criteria shortened, about 7 wordsv265
  5. Minor 4 versions Re-verified since Jul 9, 2025, no change to tracked fieldsv261-v264
Show 41 earlier versionsHide 41 earlier versions
  1. Minor Eligibility criteria shortened, about 2 wordsv260
  2. Minor Re-verified, no change to tracked fieldsv259
  3. Minor Start date changed from estimate of May 12, 2025 to May 5, 2025v258
  4. Minor Start date: May 11, 2025 to May 12, 2025v257
  5. Minor Start date: May 8, 2025 to May 11, 2025v256
  6. Minor Start date: May 7, 2025 to May 8, 2025v255
  7. Minor Start date: May 6, 2025 to May 7, 2025v254
  8. Minor Start date: May 5, 2025 to May 6, 2025v253
  9. Minor Start date: May 4, 2025 to May 5, 2025v252
  10. Minor Start date: May 1, 2025 to May 4, 2025v251
  11. Minor Start date: Apr 30, 2025 to May 1, 2025v250
  12. Minor Start date: Apr 29, 2025 to Apr 30, 2025v249
  13. Minor Start date: Apr 28, 2025 to Apr 29, 2025v248
  14. Minor Start date: Apr 27, 2025 to Apr 28, 2025v247
  15. Minor Start date: Apr 24, 2025 to Apr 27, 2025v246
  16. Minor Start date: Apr 23, 2025 to Apr 24, 2025v245
  17. Minor Start date: Apr 22, 2025 to Apr 23, 2025v244
  18. Minor Start date: Apr 21, 2025 to Apr 22, 2025v243
  19. Minor Start date: Apr 20, 2025 to Apr 21, 2025v242
  20. Minor Start date: Apr 16, 2025 to Apr 20, 2025v241
  21. Minor Start date: Apr 15, 2025 to Apr 16, 2025v240
  22. Minor Start date: Apr 13, 2025 to Apr 15, 2025v239
  23. Minor Start date: Apr 10, 2025 to Apr 13, 2025v238
  24. Minor Start date: Apr 9, 2025 to Apr 10, 2025v237
  25. Minor Start date: Apr 8, 2025 to Apr 9, 2025v236
  26. Minor Start date: Apr 7, 2025 to Apr 8, 2025v235
  27. Minor Start date: Apr 4, 2025 to Apr 7, 2025v234
  28. Minor Start date: Apr 3, 2025 to Apr 4, 2025v233
  29. Minor Start date: Apr 1, 2025 to Apr 3, 2025v232
  30. Minor Start date: Mar 31, 2025 to Apr 1, 2025v231
  31. Minor Start date: Mar 30, 2025 to Mar 31, 2025v230
  32. Minor Start date: Mar 27, 2025 to Mar 30, 2025v229
  33. Minor Start date: Mar 26, 2025 to Mar 27, 2025v228
  34. Minor Start date: Mar 25, 2025 to Mar 26, 2025v227
  35. Minor Start date: Mar 24, 2025 to Mar 25, 2025v226
  36. Minor Start date: Mar 23, 2025 to Mar 24, 2025v225
  37. Minor Start date: Mar 20, 2025 to Mar 23, 2025v224
  38. Minor Start date: Mar 19, 2025 to Mar 20, 2025v223
  39. Minor Start date: Mar 18, 2025 to Mar 19, 2025v222
  40. Minor Start date: Mar 17, 2025 to Mar 18, 2025v221
  41. Minor Start date: Mar 16, 2025 to Mar 17, 2025v220
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years. Objective: To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis. Eligibility: People aged 18 years and older with interstitial lung disease or lung fibrosis. Design: Participants will have at least 7 clinic visits over 5 months. Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include: Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe. Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood. Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest. 6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked. Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Participants who decide to continue longer may enter an optional 12 week extension phase, for a maximum treatment time of 24 weeks. Tests will be repeated at study visits.
Trial Details
NCT Number NCT06325696
Lead Sponsor National Institute of Environmental Health Sciences (NIEHS)
Conditions
(from sponsor)
Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
Related terms Idiopathic Pulmonary Fibrosis, Lung Diseases, Lung Diseases, Interstitial, Pulmonary Fibrosis
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov