Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis (NCT07679893)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (27 items).
Location: Trial Management Group Inc — Windsor, Ontario
Age range: 40 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Trial Management Group Inc — Windsor, Ontario
📞 Contact the Study Coordinator
Phone: (203) 796-3407
Email: wfares@mannkindcorp.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Idiopathic Pulmonary Fibrosis
- Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis — Birmingham, Alabama
- Atezolizumab for Idiopathic Pulmonary Fibrosis — Los Angeles, California
- Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis — Worcester, Massachusetts
- A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) — Quilmes, Buenos Aires
- Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF — St John's,
Explore by condition: All Idiopathic Pulmonary Fibrosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.