[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645054":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":31,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Mannkind Corporation","INDUSTRY",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Nintedanib DPI 4X day","EXPERIMENTAL","Inhalable",[13],"Drug: Nintedanib Dry Powder Inhalation",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo 4X day","PLACEBO_COMPARATOR",[18],"Drug: Placebo",{"label":20,"type":10,"description":11,"interventionNames":21},"Nintedanib 2X day",[13],{"label":23,"type":16,"description":11,"interventionNames":24},"Placebo 2X day",[18],[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Nintedanib Dry Powder Inhalation","Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.",[20,9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Placebo","Placebo oral inhalation powder",[23,15],[37],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD","CONTACT","203-796-3407","wfares@mannkindcorp.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Trial Management Group Inc","RECRUITING","Windsor","Ontario","N8X1T3","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-83.01654,42.30008,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":31,"email":61},"Syed Anees","416-929-7717","aneesresearch@yahoo.com",{"type":63,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100645054","phase-2-phase-2-clinical-trial-of-mnkd-201-nintedanib-dry-powder-inhalation-in-patients-with-idiopathic-pulmonary-fibrosis-100645054",false,"NCT07679893","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","INFLO-2","Inclusion Criteria:\n\n* 40-80 years old when signing consent and entering screening.\n* Diagnosed with IPF based on current ATS\u002FERS\u002FJRS\u002FALAT guidelines.\n* Either new to treatment or on a stable dose of pirfenidone and\u002For nerandomilast for at least 3 months before screening.\n* Weighs more than 40 kg (88 lb) at screening.\n* Women who can become pregnant:\n* Must have a negative pregnancy test at screening.\n* Must use an approved birth control method from screening until at least 1 month after the last study dose.\n* Men who can father a child and are sexually active with women who can become pregnant:\n* Must use an approved birth control method during treatment and for at least 3 months after the last study dose.\n* Must not donate sperm during treatment and for at least 3 months after the last study dose.\n* Willing to follow all study rules and restrictions.\n* Willing and able to attend study visits and complete study procedures.\n* Able to perform spirometry (lung function testing) as required by the study.\n\nExclusion Criteria:\n\n* Has a lung disease caused by something other than IPF.\n* Has a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).\n* Has another condition that significantly affects breathing.\n* Has serious heart or blood vessel disease.\n* Has a recent or current infection.\n* Was recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.\n* Has a history of asthma (except childhood asthma that has resolved).\n* Has another medical condition or abnormal test result that may affect study participation or safety.\n* Cannot perform high-quality spirometry testing.\n* Has obstructive lung disease.\n* Has abnormal liver function tests.\n* Has moderate to severe liver disease.\n* Has severe kidney disease.\n* Has recently used high-dose steroids or other immune-suppressing medications.\n* Has active cancer or recent cancer treatment.\n* Is on, or expected to be added to, a transplant list.\n* Had major surgery recently or has planned procedures that could interfere with the study.\n* Has had a severe reaction to nintedanib or cannot take nintedanib safely.\n* Has recently used certain medications that may interact with the study drug.\n* Is currently using, or plans to use, prohibited medications during the study.\n* Has recently participated in another clinical trial.\n* Has current alcohol or drug abuse issues.\n* Donated a significant amount of blood recently.\n* Received a live vaccine recently.\n* Currently smokes, recently smoked, or quit smoking less than 1 year ago.\n* Requires more than 6 L\u002Fmin of oxygen while at rest.","ALL","40 Years","80 Years",{"count":76,"type":77},210,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","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\u002FFVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.",[83,84],"Idiopathic Pulmonary Fibrosis","Idiopathic Pulmonary Fibrosis (IPF)",[86,87,88,89,90],"inhalable treatments","lung scarring","Pulmonary fibrosis","fibrosis","pulmonary","2026-07-23",{"date":93,"type":94},"2026-07-24","ACTUAL",{"date":96,"type":77},"2026-06-30",{"date":98,"type":77},"2028-12",{"name":5,"class":6},1]