A Phase 2 interventional study of Nintedanib Dry Powder Inhalation and Placebo in Idiopathic Pulmonary Fibrosis and Idiopathic Pulmonary Fibrosis (IPF), sponsored by Mannkind Corporation. Recruiting at 1 site in Canada. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Mannkind Corporation · Phase 2, Interventional, and Treatment
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.
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
This study's planned enrollment of 153 is above the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Mannkind Corporation is the lead sponsor of 57 studies on the registry; 3 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inhalable
Drug: Nintedanib Dry Powder Inhalation
Inhalable
Drug: Placebo
2nd dose
Drug: Nintedanib Dry Powder Inhalation
2nd dose
Drug: Placebo
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Placebo oral inhalation powder
Safety and Efficacy
Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)
Time frame: From enrollment to the end of randomized treatment at 12 weeks
Events of clinical bronchospasm
Events of clinical bronchospasm (e.g., treatment-emergent adverse event \[TEAE\] of wheezing or chest tightness immediately after inhalation)
Time frame: From enrollment to the end of open-label treatment at 36 weeks
FEV1 change
Change in forced expiratory volume in 1 second (FEV1) (mL)
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Spirometry Change
Change in FEV1/forced vital capacity (FVC) ratio
Time frame: enrollment to end of open label at 36 weeks
Study Drug Discontinuation
Rate of study drug discontinuations
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Study Drug Dose Reductions
Rate of study drug dose reductions
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Adverse Events
Rate of TEAEs
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Related Adverse Events
Rate of treatment-related adverse events (TRAEs)
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Serious Adverse Events
Rate of serious adverse events (SAEs)
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Efficacy of Nintedanib DPI
To assess a potential efficacy signal of different doses of Nintedanib DPI over 12 weeks in patients with IPF.
Time frame: From enrollment to the end of randomized treatment at 12 weeks
Plan to share: No
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Idiopathic Pulmonary Fibrosis →