Testing a new medication for lung damage after stem cell transplant

Plain-English translation of NCT03805477 on ClinicalTrials.gov ↗ · Source last updated December 2025 · Translation generated August 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 study is testing a medication called in patients who have developed a serious lung complication called bronchiolitis obliterans syndrome (BOS) after receiving a stem cell transplant. BOS causes scarring and narrowing of the small airways in the lungs, which makes it hard to breathe. The medication works by blocking certain growth signals that may drive this scarring process, and researchers want to see if it is safe and tolerable for patients with this condition.

BOS is a serious complication that develops in some patients after stem cell transplant, and it has a poor outlook—many patients experience worsening lung function over time. Currently, there are limited treatment options that can stop or slow this damage, so researchers are testing whether this medication can help by reducing the scarring and fibrosis in the lungs.

Do you qualify?

You likely qualify if…

you received a stem cell transplant 5 years ago or more recently
you have been diagnosed with bronchiolitis obliterans syndrome (BOS) within the past 6 months, or have an older BOS diagnosis with significant recent worsening of lung function
your lung function tests show specific patterns of airway damage consistent with BOS
you do not currently require full-time oxygen therapy or breathing support
you are able to give informed consent and return for repeated lung function tests

You likely don't qualify if…

you are allergic or intolerant to Nintedanib or any of its ingredients
you are pregnant, planning to become pregnant, or nursing
you have had a recent lung or airway infection within the past 4 weeks
you have severe liver disease (very high liver enzyme levels unless explained by other transplant complications)
you are taking blood-thinning medications (anticoagulants) for treatment purposes, or have active heart chest pain, recent abdominal surgery, or an untreated stomach ulcer

What participation looks like

If you join this trial, you will take the medication by mouth twice a day as a capsule. You will attend regular study visits to have your lung function tested, answer questions about your symptoms and side effects, and have blood tests to monitor your health and safety. The study is designed to enroll about 20 patients total, and your participation will help researchers understand whether this medication is safe and well tolerated for people with BOS after stem cell transplant.

AI-generated summary from trial data · Aug 20, 2026 · Not medical advice

Trial locations(3 sites)

Saudi Arabia

King Faisal Specialist Hospital & Research Centre, Riyadh

Switzerland

Clinic of Hematology, University Hospital Basel, Basel

Clinic of Respiratory Medicine, University Hospital Basel, Basel