Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
Conditions
Keywords
inhalable treatments, lung scarring, Pulmonary fibrosis, fibrosis, pulmonary
Brief summary
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.
Interventions
DRUGNintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
DRUGPlacebo
Placebo oral inhalation powder
Sponsors
Mannkind Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
12 weeks parallel treatment followed by 24 weeks open label treatment of nintedanib.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 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. * Has moderate to severe liver disease. * Has severe kidney disease. * Has recently used high-dose steroids or other immune-suppressing medications. * Has active cancer or recent cancer treatment. * 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 had a severe reaction to nintedanib or cannot take nintedanib safely. * 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 recently participated in another clinical trial. * Has current alcohol or drug abuse issues. * Donated a significant amount of blood recently. * Received a live vaccine recently. * Currently smokes, recently smoked, or quit smoking less than 1 year ago. * Requires more than 6 L/min of oxygen while at rest.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Efficacy | From enrollment to the end of randomized treatment at 12 weeks | Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI) |
| Events of clinical bronchospasm | From enrollment to the end of open-label treatment at 36 weeks | Events of clinical bronchospasm (e.g., treatment-emergent adverse event \[TEAE\] of wheezing or chest tightness immediately after inhalation) |
| FEV1 change | From enrollment to the end of open-label treatment at 36 weeks | Change in forced expiratory volume in 1 second (FEV1) (mL) |
| Spirometry Change | enrollment to end of open label at 36 weeks | Change in FEV1/forced vital capacity (FVC) ratio |
| Study Drug Discontinuation | From enrollment to the end of open-label treatment at 36 weeks | Rate of study drug discontinuations |
| Study Drug Dose Reductions | From enrollment to the end of open-label treatment at 36 weeks | Rate of study drug dose reductions |
| Adverse Events | From enrollment to the end of open-label treatment at 36 weeks | Rate of TEAEs |
| Related Adverse Events | From enrollment to the end of open-label treatment at 36 weeks | Rate of treatment-related adverse events (TRAEs) |
| Serious Adverse Events | From enrollment to the end of open-label treatment at 36 weeks | Rate of serious adverse events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Nintedanib DPI | From enrollment to the end of randomized treatment at 12 weeks | To assess a potential efficacy signal of different doses of Nintedanib DPI over 12 weeks in patients with IPF. |
Countries
Canada
Contacts
CONTACTWassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD
Outcome results
None listed