Recruiting

Testing an inhaled medication for progressive lung scarring

Plain-English translation of NCT06329401 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing whether pirfenidone solution for inhalation () — a medication you breathe in — can help slow the progression of lung scarring in people whose lung disease is getting worse despite current treatments. You would receive either the medication at a high dose, a low dose, or a placebo (inactive treatment), along with your regular care. The study will follow you for one year to see if this medication helps protect your lung function.

Many people with progressive lung scarring conditions continue to get worse even when taking approved medications by mouth. This trial is exploring whether delivering the medication directly to the lungs through inhalation might work better and with fewer side effects than the current oral form.

Do you qualify?

You likely qualify if…

you have been diagnosed with progressive pulmonary fibrosis or a related lung scarring condition and show evidence that your disease is worsening
your lung function tests show a decline of at least 5–10% in the past two years, and/or your lung scans show worsening scarring patterns
your lung function is still in a certain range (your breathing capacity is at least 45% of normal, and your oxygen transfer ability is at least 30% of normal)
you can reliably perform breathing tests that meet medical standards
if you are taking nintedanib, you have been on it for at least 6 months, or you stopped it at least 12 weeks before screening

You likely don't qualify if…

you have taken oral pirfenidone in the past 3 months
you have liver enzyme levels that are more than 3 times the upper limit of normal, or high bilirubin levels
you have severe kidney disease with a creatinine clearance below 30 mL/min
you are unable to perform acceptable breathing tests

What participation looks like

You would visit the research clinic multiple times over 52 weeks (about one year). At these visits, you would have breathing tests, lung scans, blood work, and check-ins about your symptoms. You would inhale your assigned treatment (either the medication or placebo) twice a day at home. The research team will monitor your lung function and overall health throughout the year to see how the treatment affects your disease progression.

AI-generated summary from trial data · Jun 2, 2026 · Not medical advice

Trial locations(152 sites)

United States

University of Alabama at Birmingham, Birmingham, Alabama

Mayo Clinic- Scottsdale, Scottsdale, Arizona

University of Southern California, Los Angeles, California

Cedars-Sinai, Los Angeles, California

UCLA, Los Angeles, California