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New pill aims to quiet debilitating cough in lung scarring disease

NCT ID NCT06360094

Symptom relief Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested an experimental drug called BI 1839100 in adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have a chronic cough. Participants took different doses of the drug or a placebo for 12 weeks. The goal was to see if the drug could reduce coughing, measured with a portable device and questionnaires. The study was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 1839100
What this could lead to
If it works, this could lead to a new treatment that reduces chronic coughing in people with pulmonary fibrosis.
What could go wrong
The trial was terminated early, so results may be incomplete. It is a phase 2 study with only 85 participants, so even if effective, more testing is needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

85 people

The number who actually took part.

Started

Aug 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 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 * 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 * 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 Further inclusion criteria apply. Exclusion criteria for IPF and PPF cohorts: * Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1 * Forced expiratory volume in 1 second (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 Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis Progressive pulmonary fibrosis

Contacts and locations

Locations

  • A & A Research Consultants, LLC

    Edinburg, Texas, 78539, United States

  • Advanced Pulmonary Research

    Warren, Michigan, 48088, United States

  • Affiliated Hospital, Xuzhou Medical college

    Xuzhou, 221009, China

  • Akershus Universitetssykehus HF

    Lørenskog, 1478, Norway

  • Amphia Ziekenhuis

    Breda, 4818 CK, Netherlands

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128, Italy

  • CHR de la Citadelle

    Liège, 4000, Belgium

  • CIMS Studienzentrum Bamberg GmbH

    Bamberg, 96049, Germany

  • CTC Clinical Trial Consultants AB

    Uppsala, 752 37, Sweden

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 3E4, Canada

  • China Shenyang Chest Hospital

    Shenyang, 110000, China

  • Christchurch Hospital

    Christchurch, 8011, New Zealand

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, 15801, United States

  • Clinical Research Specialists LLC - Kissimmee

    Kissimmee, Florida, 34746, United States

  • Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine

    New Bern, North Carolina, 28562, United States

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Critical Care, Pulmonary and Sleep Associates

    Lakewood, Colorado, 80228, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    Rotterdam, 3015 GD, Netherlands

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120, China

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168, Italy

  • Gordon & Leslie Diamond Health Care Centre (UBC)

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Greenlane Clinical Centre

    One Tree Hill, Auckland, 1051, New Zealand

  • HOP Avicenne

    Bobigny, 93000, France

  • HOP Bretonneau

    Tours, 37000, France

  • HOP CHU Caen

    Caen, 14033, France

  • HOP Michallon

    La Tronche, 38700, France

  • HOP Nord Laennec

    Nantes, 44093, France

  • HOP d'Angers

    Angers, 49933, France

  • HYKS Keuhkosairauksien tutkimusyksikkö

    Helsinki, 00029, Finland

  • Haukeland Universitetssykehus

    Bergen, N-5021, Norway

  • Hospital Central de Asturias

    Oviedo, 33011, Spain

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28223, Spain

  • Hospital Sultan Idris Shah Serdang

    Kajang, 43000, Malaysia

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital de Galdakao

    Galdakao, 48960, Spain

  • Hospital of Heraklion (PAGNI)

    Crete, 71500, Greece

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inje University Sanggye Paik Hospital

    Seoul, 01757, South Korea

  • Institut Perubatan Respiratori

    Kuala Lumpur, 53000, Malaysia

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Krankenhaus Bethanien gGmbH

    Solingen, 42699, Germany

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • Launceston Respiratory & Sleep Centre

    Launceston, Tasmania, 7250, Australia

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406, United States

  • Lung Research Victoria

    Footscray, Victoria, 3011, Australia

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Memorial Hospital Gulfport

    Gulfport, Mississippi, 39501, United States

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655, Japan

  • National Hospital Organization Himeji Medical Center

    Hyogo, Himeji, 670-8520, Japan

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563, Japan

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549, United States

  • Odense University Hospital

    Odense, 5000, Denmark

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372, Norway

  • Ospedale Classificato San Giuseppe

    Milan, 20123, Italy

  • Oulun yliopistollinen keskussairaala

    Oulu, 90220, Finland

  • People's Hospital of Sichuan Province

    Chengdu, 610072, China

  • Pol. Universitario Tor Vergata

    Roma, 00133, Italy

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230, United States

  • Ramathibodi Hospital

    Ratchatewi, 10400, Thailand

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • Royal Devon and Exeter Hospital, Wonford

    Exeter, EX2 5DW, United Kingdom

  • Royal Lancaster Infirmary

    Lancaster, LA1 4RP, United Kingdom

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239, Germany

  • Sapporo Medical University Hospital

    Hokkaido, Sapporo, 060-8543, Japan

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • Skånes universitetssjukhus, Lund

    Lund, 221 85, Sweden

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Southeastern Research Center-Winston Salem-69289

    Winston-Salem, North Carolina, 27103, United States

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303, United States

  • Srinagarind Hospital

    Khon Kaen, 40002, Thailand

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6, Canada

  • TYKS

    Turku, 20520, Finland

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • The Iowa Clinic, PC

    West Des Moines, Iowa, 50266, United States

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011, China

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126, Germany

  • Tianjin Medical University General Hospital

    Tianjin, 30052, China

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541, Japan

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503, Japan

  • Univ. Gen. Hosp. of Patras

    Pátrai, 26504, Greece

  • University Thomayer´s Hospital

    Prague, 140 59, Czechia

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Fukui Hospital

    Fukui, Yoshida-gun, 910-1193, Japan

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Waikato Hospital

    Hamilton, 3240, New Zealand

  • West China Hospital of Sichuan University

    Chengdu, 610041, China

  • Wythenshawe Hospital

    Manchester, M23 9LT, United Kingdom

  • Zhejiang Hospital

    Hangzhou, 310013, China

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Other studies related to the condition(s) this trial covers.