H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNational Institute of Environmental Health Sciences (NIEHS)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability of subject to understand, and the willingness to sign a written informed consent document and comply with requirements of the study
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or Female participants ages >18 years
MD diagnosis of Idiopathic Pulmonary Fibrosis or other progressive ILD as defined previously
Disqualifiers
Active on lung transplantation list
On supplemental oxygen at rest
Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis
Known diagnosis of celiac disease or wheat or gluten allergies
Trial design
Design model
Single group
Treatments tested in this trial
hymecromone
Drug400 mg
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD
Time frame
Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeksSecondary outcomes
1
Evaluate the safety and tolerability of oral H01 in participants with progressive ILD.
Time frame
On-going throughout study; each study visit2
Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01.
Time frame
On-going throughout study; each study visit3
Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01.
Time frame
On-going throughout study; each study visit4
Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01.
Time frame
On-going throughout study; each study visitSponsors and contacts
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Source ClinicalTrials.gov