Is NCT06325696 recruiting in Research Triangle Park, NC?

Yes, NCT06325696 is currently recruiting participants at its Research Triangle Park, NC location. This interstitial lung disease clinical trial is actively enrolling qualified participants.

Is participation in this Research Triangle Park clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Interstitial Lung Disease Clinical Trial in Research Triangle Park, NC

Q: How do I join the interstitial lung disease clinical trial in Research Triangle Park?

To join this clinical trial in Research Triangle Park, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Interstitial Lung Disease Study in Research Triangle Park

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. Tests will be repeated at study visits.

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

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

DLCO\>30% and FVC\>45%

Subjects in reproductive age who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive

Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

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

Cirrhosis or active viral or non-viral hepatitis: Bilirubin, AST and ALT values higher than twice the upper range of normal, or a Child-Pugh score of 7 or more

Subjects with history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills

Subjects with significant renal impairment defined as eGFR lower than 40 ml/min.

Subjects with a baseline corrected Fridericia's QT interval (QTcF) \>450ms or baseline ECG abnormalities which, in the opinion of the study physician, are clinically significant and would place the participant at increased risk for adverse effects.

Subjects with ongoing alcohol or illegal drug use disorder

Subjects who are pregnant, lactating or attempting to conceive

Participants able to become pregnant (have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed) must use effective birth control methods to try and not become pregnant while participant in this study. Methods include (a) partner vasectomy, (b) bilateral tubal ligation, (c) intrauterine devices (IUDs), (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).

Male participants able to father children with a partner able to become pregnant must agree to use effective birth control (listed above) to participate in this study.

Known allergy to hymecromone or any component thereof

Chronic therapy with medications that are known potent human UDP-glucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus.

Physician concern that participant may not adhere to the study protocol

Current participation in another clinical treatment trial for ILD. May participate after 12 weeks from conclusion of another treatment trial.

Changing dose of other ILD medications over the 3 months prior to baseline

Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that place the participant at increased risk for adverse effects, as determined by the study physician.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Research Triangle Park?

Yes, this clinical trial (NCT06325696) has an active research site in Research Triangle Park, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Interstitial Lung Disease Treatment Options in Research Triangle Park, NC

If you're searching for interstitial lung disease treatment options in Research Triangle Park, NC, this clinical trial (NCT06325696) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Research Triangle Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced interstitial lung disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all interstitial lung disease clinical trials near you to find additional studies recruiting in your area.

Interstitial Lung Disease Clinical Trial in Research Triangle Park, NC

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