Inhaled nintedanib powder for adults with idiopathic pulmonary fibrosis
Tests inhaled nintedanib powder against placebo in adults with idiopathic pulmonary fibrosis.
Plain-language title generated from the registry record
Registry title: Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
Key facts
- Where
- Windsor, CanadaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT07679893, who can take part
Where in Canada
- Trial Management Group IncWindsor, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mannkind Corporation
- Trial code
- NCT07679893
- Record updated
- 14 September 2026
- Original description
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 BID, 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.Read full original descriptionShow less
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
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 BID, 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.
Inclusion: 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: Has recently used high-dose steroids or other immune-suppressing medications; 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 recently used certain medications that may interact with the study drug; Is currently using, or plans to use, prohibited medications during the study; Has current alcohol or drug abuse issues; Received a live vaccine recently; 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; Has obstructive lung disease; Has moderate to severe liver disease; Has severe kidney disease; Has active cancer or recent cancer treatment; Cannot perform high-quality spirometry testing; Has abnormal liver function tests; Has had a severe reaction to nintedanib or cannot take nintedanib safely; Has recently participated in another clinical trial; Donated a significant amount of blood recently; Currently smokes, recently smoked, or quit smoking less than 1 year ago; Requires more than 6 L/min of oxygen while at rest.