idiopathic pulmonary fibrosis or progressive pulmonary fibrosis with clinically meaningful cough
Conditions
Interventions
3 doses of BI 1839100 to placebo over 12 weeks for the IPF cohort. A positive outcome at Week 4 interim analysis of IPF cohort will allow for the inclusion of an exploratory PPF cohort assessing 1 dos
Sponsors
Adachi Sayaka
Eligibility
Inclusion criteria
Inclusion criteria: IPF or PPF diagnosis Chronic cough (>8 weeks) due to IPF or PPF, refractory to treatment Cough Severity VAS >=30 mm at Visit 1 and Visit 2B FVC >=45% of predicted normal at Visit 1 Diffusing capacity of the lungs for carbon monoxide(DLCO) >=25% of predicted normal at Visit 1 On stable therapy or not on therapy with nintedanib (IPF and PPF cohorts) or pirfenidone
Exclusion criteria
Exclusion criteria: Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1 Forced Expiratory Volume in 1 second (FEV1)/FVC <0.7 at Visit 1 Known reversible airflow obstruction/response to bronchodilators Other clinically significant pulmonary abnormalities Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 Ongoing chronic pulmonary infection 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline in 24-h cough frequency (CC/h) | — |
Countries
Germany, Japan, US
Contacts
Public ContactTetsuya Katakabe
Boehringer Ingelheim
Outcome results
None listed