Inhaled drug could offer new hope for lung scarring disease
NCT ID NCT07679893
First seen Jul 01, 2026 · Last updated Sep 15, 2026 · Updated 8 times
Summary
This phase 2 trial tests whether an inhaled form of nintedanib (MNKD-201) is safe and effective for people with idiopathic pulmonary fibrosis (IPF), a disease that causes lung scarring. About 210 adults with IPF will receive either a low or high dose of the inhaled drug or a placebo for 12 weeks, followed by a period where everyone gets the active drug. The study focuses on safety, especially breathing problems right after inhalation, and changes in lung function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nintedanib dry powder inhalation
- What this could lead to
- If successful, this could offer a more targeted, inhaled treatment for IPF, potentially reducing side effects compared to the oral version.
- What could go wrong
- This is an early phase 2 trial with a small number of participants. The inhaled drug may cause bronchospasm or other side effects, and it may not prove effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 153 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Trial Management Group Inc
RECRUITINGWindsor, Ontario, N8X1T3, Canada
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