A study to test whether BI 1839100 improves cough in people with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis

Prior treatment

• IPF and PPF cohorts: Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
• IPF and PPF cohorts: Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
• IPF and PPF cohorts: Current smokers (tobacco use within the 6 months prior to Visit 1)
• IPF and PPF cohorts: Initiation or change in supplemental oxygen requirement during 4 weeks prior to Visit 1

Other illness

• IPF and PPF cohorts: In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic or bronchiectatic disorder
• IPF and PPF cohorts: Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)

Other

• IPF and PPF cohorts: Forced expiratory volume in 1 second (FEV1)/FVC <0.7 at Visit 1
• IPF and PPF cohorts: Known reversible airflow obstruction/response to bronchodilators
• Further exclusion criteria apply.

• IPF cohort: Diagnosis of IPF.
• PPF cohort: Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B.
• PPF cohort: FVC ≥45% of predicted normal at Visit 1
• PPF cohort: DLCO ≥25% of predicted normal at Visit 1
• PPF cohort:If receiving immunomodulatory therapy for ILD, allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)
• PPF cohort: 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 therapy for the purpose of participating in this trial
• PPF cohort: Patients aged >18 years when signing the informed consent
• Further inclusion criteria apply.
• IPF cohort: Chronic cough (>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment).
• IPF cohort: Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B.
• IPF cohort: FVC ≥45% of predicted normal at Visit 1.
• IPF cohort: Diffusing capacity of the lungs for carbon monoxide (DLCO) >25% of predicted normal at Visit 1.
• IPF cohort: 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 AFtreatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic (AF) treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial.
• IPF cohort: Patients aged ≥40 years when signing the informed consent.
• PPF cohort: Diagnosis of PPF.
• PPF cohort: Chronic cough (>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment).