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

JRCT ID: jRCT2071240044

Registered date:02/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: idiopathic pulmonary fibrosis or progressive pulmonary fibrosis with clinically meaningful cough
• Date of first enrollment: 09/08/2024
• Target sample size: 230
• Countries of recruitment: Germany,Japan,US,Japan
• Study type: Interventional
• Intervention(s): 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 dose of BI 1839100 compared with placebo over 4 weeks.

Outcome(s)

• Primary Outcome: change from baseline in 24-h cough frequency (CC/h)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include 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

Exclude 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

Related Information

• Primary Sponsor: Adachi Sayaka