BridgeMD
A study to test whether BI 1839100 improves cough in people with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis
EU CTIS ID: 2023-510249-79-00
What this study is testing
Phase IIa: To demonstrate a meaningful reduction from baseline in 24-h cough frequency in the highest dose group of BI 1839100 compared with placebo after 4 weeks of treatment. Phase IIb: To demonstrate a non-flat dose-response curve with respect to change from baseline in 24-h cough frequency after 12 weeks of treatment and characterize the dose-response relationship within the therapeutic range of BI 1839100 regarding efficacy and safety.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- IPF and PPF cohorts: Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
- 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
- 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: Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
- IPF and PPF cohorts: Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
See the full eligibility criteria
- 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).
- IPF and PPF cohorts: Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
- 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
- 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: Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
- IPF and PPF cohorts: Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
- 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
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- New Zealand
- United States
- Argentina
- Canada
- United Kingdom
- Japan
- Korea, Republic of
- Singapore
- Australia
- China
- Brazil
- Malaysia
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; New Zealand; United States; Argentina; Canada; United Kingdom and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.