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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nintedanib Dry Powder Inhalation
  • Placebo

Treatment groups

210 Participants
are divided into 4 treatment groups

Locations

1
Mannkind Corporation06810, DanburyConnecticut, United States

Sponsors and collaborators

Mannkind Corporation

Lead sponsor