A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

Launched by BOEHRINGER INGELHEIM · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called BI 1839100 to see if it can help reduce coughing in adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). To participate, you must be at least 40 years old with IPF or 18 years old with PPF, and you need to have a chronic cough that has lasted for more than 8 weeks. Participants will be randomly assigned to receive either BI 1839100 in different doses or a placebo, which looks the same but has no medication. The treatment lasts for three months, and during this time, participants will visit the study site seven times for health checks and breathing tests.

Throughout the study, participants will use a special device to measure their coughing over 24 hours each month and will fill out questionnaires about their cough. Researchers will compare how well BI 1839100 works against the placebo and will also keep track of any side effects. This trial is currently seeking participants, and it aims to learn more about how this treatment affects both coughing and lung function in those living with these conditions.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• For Idiopathic Pulmonary Fibrosis (IPF) cohort:
• • Minimum age: 40 years
• • Diagnosis of IPF
• • Chronic cough (\>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment)
• • Cough Severity visual analogue scale (VAS) ≥30 mm at Visit 1 and Visit 2B
• • Forced vital capacity (FVC) ≥45% of predicted normal at Visit 1
• • Diffusing capacity of the lungs for carbon monoxide (DLCO) \>25% of predicted normal at Visit 1
• * Patients may be either:
• • On stable therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration. Combination of nintedanib plus pirfenidone will not be allowed
• • Not on therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 (either antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
• • Patients aged ≥40 years when signing the informed consent
• For Progressive Pulmonary Fibrosis (PPF) cohort:
• • Minimum age: 18 years
• • Diagnosis of PPF
• • Chronic cough (\>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment)
• • Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B
• • FVC ≥45% of predicted normal at Visit 1
• • DLCO ≥25% of predicted normal at Visit 1
• • If receiving immunomodulatory therapy for interstitial lung disease (ILD), allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)
• * Patients may be either:
• • On a stable therapy with nintedanib for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration
• • Not on a therapy with nintedanib for ≥12 weeks prior to Visit 1 (either AF-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
• • Patients aged \>18 years when signing the informed consent Further inclusion criteria apply.
• Exclusion criteria for IPF and PPF cohorts:
• • Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
• • Forced expiratory volume in 1 second (Forced expiratory volume in 1 second (FEV1))/FVC \<0.7 at Visit 1
• • Known reversible airflow obstruction/response to bronchodilators
• • In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic and bronchiectatic disorder
• • Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
• • Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
• • Current smokers (tobacco use within the 6 months prior to Visit 1)
• • Initiation or change in supplemental oxygen requirement during 4 weeks prior to Visit 1 Further exclusion criteria apply.