Study on BI 1839100 for Reducing Cough in Patients with Idiopathic or Progressive Pulmonary Fibrosis

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What is this study about?

This clinical trial is focused on studying two lung diseases: Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). These conditions are characterized by scarring of the lung tissue, which can lead to a persistent cough and difficulty breathing. The trial will test a new treatment called BI 1839100, which is taken as a film-coated tablet. The purpose of the study is to see if this medication can help reduce cough in people with these lung conditions.

Participants in the study will be randomly assigned to receive either the BI 1839100 tablet or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for 12 weeks, during which the participants will take the medication orally. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

The main goal is to observe any changes in the frequency of coughing over the course of the study. Researchers will also look at how different doses of BI 1839100 affect cough frequency and assess the safety of the medication. This study aims to provide valuable information on whether BI 1839100 can be an effective treatment for reducing cough in patients with Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis.

1 Joining the study

Upon joining the study, the patient will be randomly assigned to receive either the medication BI 1839100 or a placebo. The placebo is designed to look identical to the medication to ensure the study remains unbiased.

The medication is administered in the form of a film-coated tablet and is taken orally.

2 Initial treatment phase

During the first 4 weeks, the patient will take the assigned tablet daily. The goal is to observe any changes in the frequency of cough over a 24-hour period.

The study aims to determine if there is a significant reduction in cough frequency in patients taking the highest dose of BI 1839100 compared to those taking the placebo.

3 Extended treatment phase

The treatment continues for a total of 12 weeks. Throughout this period, the patient will continue to take the daily tablet.

The study will assess the dose-response relationship, which means understanding how different doses of BI 1839100 affect cough frequency and safety.

4 Monitoring and assessments

Throughout the study, the patient will undergo regular assessments to monitor changes in cough frequency and severity. This includes measuring the cough frequency over 24 hours and evaluating the severity using specific scoring systems.

The study will also track any changes in lung function and overall health to ensure the safety and effectiveness of the treatment.

5 Completion of the study

At the end of the 12-week period, the patient will complete the study. Final assessments will be conducted to gather comprehensive data on the treatment’s impact.

The results will contribute to understanding the potential benefits of BI 1839100 for patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.

Who Can Join the Study?

  • For the IPF cohort (Idiopathic Pulmonary Fibrosis):
    • Must have a diagnosis of IPF.
    • Must have a chronic cough lasting more than 8 weeks, which is not responding to treatment for known causes.
    • Must have a Cough Severity VAS (Visual Analog Scale) score of 30 mm or more at specific visits.
    • Must have a FVC (Forced Vital Capacity) of 45% or more of what is predicted as normal at a specific visit. FVC is a measure of lung function.
    • Must have a DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) of more than 25% of what is predicted as normal at a specific visit. DLCO measures how well the lungs transfer gas from the air to the blood.
    • Must be on a stable therapy with nintedanib or pirfenidone for at least 12 weeks before a specific visit and plan to continue this treatment throughout the trial. Combination of both drugs is not allowed. Alternatively, must not be on these therapies for at least 12 weeks before a specific visit and do not plan to start or restart them during the trial.
    • Must be aged 40 years or older when signing the informed consent.
  • For the PPF cohort (Progressive Pulmonary Fibrosis):
    • Must have a diagnosis of PPF.
    • Must have a chronic cough lasting more than 8 weeks, which is not responding to treatment for known causes.
    • Must have a Cough Severity VAS score of 30 mm or more at specific visits.
    • Must have a FVC of 45% or more of what is predicted as normal at a specific visit.
    • Must have a DLCO of more than 25% of what is predicted as normal at a specific visit.
    • If receiving immunomodulatory therapy for ILD (Interstitial Lung Disease), allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine, and the dose must be stable for 12 weeks before a specific visit.
    • Must be on a stable therapy with nintedanib for at least 12 weeks before a specific visit and plan to continue this treatment throughout the trial. Alternatively, must not be on this therapy for at least 12 weeks before a specific visit and do not plan to start or restart it during the trial.
    • Must be aged over 18 years when signing the informed consent.
  • Both male and female participants are eligible.
  • Participants should not belong to a vulnerable population.

Who Cannot Join the Study?

  • Patients with any other lung disease besides Idiopathic Pulmonary Fibrosis (IPF) or Progressive Pulmonary Fibrosis (PPF) cannot participate. These are specific lung conditions that cause scarring in the lungs.
  • Patients who have had a recent lung infection or illness that affects their breathing may be excluded.
  • Patients who are currently taking medications that could interfere with the study drug may not be eligible.
  • Patients with a history of severe allergies or reactions to medications might be excluded.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients with certain heart conditions or other serious health issues may be excluded.
  • Patients who have participated in another clinical trial recently might not be eligible.
  • Patients who are unable to comply with the study procedures or follow-up visits may be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Centre Hospitalier Regional De La Citadelle Liege Belgium
Klinikum Wels-Grieskirchen GmbH Wels Austria
Amphia Hospital Breda The Netherlands
Hospital Universitario Infanta Leonor Madrid Spain
University General Hospital Of Heraklion Heraklion Greece
Oulu University Hospital Oulu Finland
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Hospital De Galdakao Usansolo Galdakao Spain
Universitaetsklinikum Krems Krems An Der Donau Austria
Multimedica S.p.A. Milan Italy
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
HELIOS Hanseklinikum Stralsund GmbH Stralsund Germany
Krankenhaus Bethanien gGmbH Solingen Germany
Azienda Ospedaliera di Padova Padua Italy
University General Hospital Of Ioannina Ioannina Greece
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Region Skane Skanes Universitetssjukhus Lund Sweden
IRCCS Ospedale Policlinico San Martino Genoa Italy
Turku University Hospital Turku Finland
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
CTC Clinical Trial Consultants AB Uppsala Sweden
General University Hospital Of Patras Patras Greece
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Klinikum Wuerzburg Mitte gGmbH Wuerzburg Germany
Hopital Beaujon Clichy France
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o. Lublin Poland
Fakultni Thomayerova nemocnice Prague Czechia
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hospital Universitario Virgen De La Victoria Malaga Spain
Ctfizwmxe Ugaqaqvsheqdib Sfzyemmlg Woluwe-Saint-Lambert Belgium
Ufcemuwevk Mcojpcq Cyeorq Hlwqiuhcmejhcchrz Hamburg Germany
Ouzzjezttlaien Lnbc Gjeb Linz Austria
Hfvgbxbm Umwkanxqxawfi Mkwlrzh Db Vxisllobub Santander Spain
Nljcjtop Ivxntrhjv Og Tuotlrrwazwh Aml Lzhv Danznnxl Warsaw Poland
Ajaczfctfg Pvmfusmi Hbmgosjd Dr Mqpycqqga Marseille France
Arhculcm Ufxwbzpjof Hejmxgym Lorenskog Norway
Hosgn Bvtids Hw Bergen Norway
Hwoyjjiw Uiexmhdnqn Cgsrvvp Huyvnvor Helsinki Finland
Esrwpxs Uereivjcnpcw Mlboxwm Cjqznlg Ruvpqxhdn (frveuxp Muc Rotterdam The Netherlands
Cmskwv Hupshdfdmzy Ryzsodll Ubdsyswtcvgje Db Tgjvk Tours France
Aiucwap Oyiysiequtk Ugtknuyllumtp Oxirfglu Rlftdea Foggia Italy
Ckclmi Henbgzxagqy Rcroujwr Dfxwexotdirbga Angers France
Jwneuidl Kirgka Uvrtumaxcv Linz Austria
Hnbkosqi Vdgp dqobeovj Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
05.08.2024
Belgium Belgium
Not recruiting
05.08.2024
Czechia Czechia
Not recruiting
05.08.2024
Denmark Denmark
Not recruiting
05.08.2024
Finland Finland
Not recruiting
05.08.2024
France France
Not recruiting
05.08.2024
Germany Germany
Not recruiting
05.08.2024
Greece Greece
Not recruiting
05.08.2024
Hungary Hungary
Not recruiting
05.08.2024
Italy Italy
Not recruiting
05.08.2024
Norway Norway
Not recruiting
05.08.2024
Poland Poland
Not recruiting
05.08.2024
Spain Spain
Not recruiting
05.08.2024
Sweden Sweden
Not recruiting
05.08.2024
The Netherlands The Netherlands
Not recruiting
05.08.2024

Trial locations

Investigated drugs:

BI 1839100 is an investigational medication being studied for its potential to reduce cough frequency in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis. This medication is taken orally and is being tested to see how effective and safe it is over a 12-week treatment period. The study aims to find the right dose that can significantly decrease the number of coughs a patient experiences in a day.

Idiopathic Pulmonary Fibrosis (IPF) – A chronic lung disease characterized by the thickening and scarring of lung tissue, leading to a progressive decline in lung function. The cause of IPF is unknown, and it primarily affects middle-aged and older adults. As the disease progresses, the scarring makes it increasingly difficult for the lungs to transfer oxygen into the bloodstream. Patients often experience a persistent dry cough and shortness of breath, which worsen over time. The disease can lead to a significant reduction in the ability to perform daily activities due to breathing difficulties.

Progressive Pulmonary Fibrosis (PPF) – A condition where lung tissue becomes damaged and scarred over time, leading to a gradual worsening of lung function. This disease can arise from various underlying causes, including other lung conditions or environmental exposures. As fibrosis progresses, patients may experience increasing breathlessness and a chronic cough. The scarring of lung tissue reduces the lungs’ ability to expand and contract, making breathing more difficult. Over time, the disease can severely impact the quality of life due to the progressive nature of the symptoms.

Trial ID:
2023-510249-79-00
Protocol code:
1490-0004
Trial Phase:
Therapeutic exploratory (Phase II)

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