Testing Nintedanib Dry Powder Inhalation against a placebo for idiopathic pulmonary fibrosis
Official title: Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial of the Efficacy and Safety of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis Followed by an Open-Label Extension
- Phase 2
- 4 groups
- One site, in Windsor
- Recruiting
Interventions
- Medication
Nintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
- Medication
Placebo
Placebo oral inhalation powder
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Trial Management Group Inc
Windsor, Ontario
Eligibility Criteria
See who this study is looking for39 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +40-80 years old when signing consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and entering screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +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.
- +Must use an approved birth controlControl groupThe group a new treatment is measured against.Read more → method from screening until at least 1 month after the last study dose.
- +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.
- +Women who can become pregnant:
- +Must have a negative pregnancy test at screening.
- +Men who can father a child and are sexually active with women who can become pregnant:
Exclusion
- −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.
- −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 trialInterventional studyA study where participants are given something to see what happens.Read more →.
- −Has current alcohol or drug abuse issues.
- −Donated a significant amount of blood recently.
- −Received a live vaccine recently.
- −Requires more than 6 L/min of oxygen while at rest.
- −Had major surgery recently or has planned procedures that could interfere with the study.
- −Currently smokes, recently smoked, or quit smoking less than 1 year ago.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Groups A and C receive Nintedanib Dry Powder Inhalation.
Registry label: A: Nintedanib DPI 4X day · C: Nintedanib 2X day
Groups B and D, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receive Placebo.
Registry label: B: Placebo 4X day · D: Placebo 2X day
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 40 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 210 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → treatment at 12 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Safety and Efficacy — measured over From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → treatment at 12 weeks.
Events of clinical bronchospasm — measured over From enrollment to the end of open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more → treatment at 36 weeks.
FEV1 change — measured over From enrollment to the end of open-label treatment at 36 weeks.
Spirometry Change — measured over enrollment to end of open label at 36 weeks.
The study lists 5 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07679893 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Nintedanib Dry Powder InhalationDrug
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo oral inhalation powder
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 40 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 40 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → treatment at 12 weeks.
The study as a whole is currently expected to finish around 2028-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 210 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Windsor, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg QID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1/FVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.