Last updated 10 days ago
A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
230 patients around the world
Available in Brazil, Argentina
Boehringer Ingelheim
11Research sites
230Patients around the world
This study is for people with
Pulmonary fibrosis
Idiopathic pulmonary fibrosis
Progressive Pulmonary Fibrosis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.Patients may be either: 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.Patients may be either: 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.
- 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.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.
Sites
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Hospital Británico de Buenos Aires - CABA
Centro de Investigación Clínica Belgrano S.A.
CEDIC Centro de Investigación Clínica - CABA, Buenos Aires
Consultorios Médicos del Buen Ayre
Serviços Médicos Respirar Sul Fluminense
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
CLARE - Clínica de Pneumologia SS
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Hospital Alemão Oswaldo Cruz
SponsorBoehringer Ingelheim
Conditions
Idiopathic pulmonary fibrosisProgressive Pulmonary Fibrosis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06360094
