Inhaled nintedanib powder for IPF in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial is a randomized, double-blind, placebo-controlled study of two doses of nintedanib dry powder inhalation (2 mg BID and 4 mg BID) versus placebo in adults with IPF. Participants will take the assigned treatment for 12 weeks, followed by a 24-week open-label extension where all receive the active drug. The primary focus is safety, especially bronchospasm risk, with secondary look at lung function (FEV1 and FEV1/FVC) and adverse events to gauge preliminary efficacy for IPF. Eligible adults 40–80 with IPF may participate if they are either treatment-naïve or on a stable dose of certain IPF meds, and can perform spirometry.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 40-80 years old when signing consent and entering screening.
* Diagnosed with IPF based on current ATS/ERS/JRS/ALAT guidelines.
* Either new to treatment or on a stable dose of pirfenidone and/or nerandomilast for at least 3 months before screening.
* Weighs more than 40 kg (88 lb) at screening.
* Women who can become pregnant:
* Must have a negative pregnancy test at screening.
* Must use an approved birth control method from screening until at least 1 month after the last study dose.
* Men who can father a child and are sexually active with women who can become pregnant:
* Must use an approved birth control method during treatment and for at least 3 months after the last study dose.
* Must not donate sperm during treatment and for at least 3 months after the last study dose.
* Willing to follow all study rules and restrictions.
* Willing and able to attend study visits and complete study procedures.
* Able to perform spirometry (lung function testing) as required by the study.

Exclusion Criteria:

* Has a lung disease caused by something other than IPF.
* Has a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).
* Has another condition that significantly affects breathing.
* Has serious heart or blood vessel disease.
* Has a recent or current infection.
* Was recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.
* Has a history of asthma (except childhood asthma that has resolved).
* Has another medical condition or abnormal test result that may affect study participation or safety.
* Cannot perform high-quality spirometry testing.
* Has obstructive lung disease.
* Has abnormal liver function tests.
* Has moderate to severe liver disease.
* Has severe kidney disease.
* Has recently used high-dose steroids or other immune-suppressing medications.
* Has active cancer or recent cancer treatment.
* Is on, or expected to be added to, a transplant list.
* Had major surgery recently or has planned procedures that could interfere with the study.
* Has had a severe reaction to nintedanib or cannot take nintedanib safely.
* Has recently used certain medications that may interact with the study drug.
* Is currently using, or plans to use, prohibited medications during the study.
* Has recently participated in another clinical trial.
* Has current alcohol or drug abuse issues.
* Donated a significant amount of blood recently.
* Received a live vaccine recently.
* Currently smokes, recently smoked, or quit smoking less than 1 year ago.
* Requires more than 6 L/min of oxygen while at rest.

Where it's running

• Trial Management Group Inc
  Windsor, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD
• Email: wfares@mannkindcorp.com
• Phone: 203-796-3407

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Nerandomilast in IPF and Progressive Fibrosis: Real-World Data

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• Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.