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Inhaled drug could offer new hope for lung scarring disease

NCT ID NCT07679893

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 153 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

40 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Trial Management Group Inc

    RECRUITING

    Windsor, Ontario, N8X1T3, Canada

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