A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

August 28, 2026 updated by: Boehringer Ingelheim

A Phase IIa/IIb, Randomised, Double Blind, Placebo-controlled, Parallel-group Dose-finding Study to Examine the Efficacy and Safety of BI 1839100 Administered Orally Over a 12-week Treatment Period in Patients With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis With Clinically Meaningful Cough

Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF.

Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF.

During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston Respiratory & Sleep Centre
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Lung Research Victoria
  • Belgium
      • Liège, Belgium, 4000
        • CHR de la Citadelle
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre (UBC)
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • China
      • Changsha, China, 410011
        • The Second Xiangya Hospital Of Central South University
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, China, 610072
        • People's Hospital of Sichuan Province
      • Guangzhou, China, 510120
        • First Affiliated Hospital of Guangzhou Medical University
      • Hangzhou, China, 310013
        • Zhejiang Hospital
      • Hefei, China, 230001
        • Anhui Provincial Hospital
      • Nanjing, China, 210008
        • Nanjing Drum Tower Hospital
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
      • Shenyang, China, 110000
        • China Shenyang Chest Hospital
      • Tianjin, China, 30052
        • Tianjin Medical University General Hospital
      • Xuzhou, China, 221009
        • Affiliated Hospital, Xuzhou Medical college
  • Czechia
      • Prague, Czechia, 140 59
        • University Thomayer´s Hospital
  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital
  • Finland
      • Helsinki, Finland, 00029
        • HYKS Keuhkosairauksien tutkimusyksikkö
      • Oulu, Finland, 90220
        • Oulun yliopistollinen keskussairaala
      • Turku, Finland, 20520
        • TYKS
  • France
      • Angers, France, 49933
        • HOP d'Angers
      • Bobigny, France, 93000
        • HOP Avicenne
      • Caen, France, 14033
        • HOP CHU Caen
      • La Tronche, France, 38700
        • HOP Michallon
      • Nantes, France, 44093
        • HOP Nord Laennec
      • Tours, France, 37000
        • HOP Bretonneau
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen, AöR
      • Bamberg, Germany, 96049
        • CIMS Studienzentrum Bamberg GmbH
      • Essen, Germany, 45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Freiburg im Breisgau, Germany, 79106
        • Universitätsklinikum Freiburg
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69126
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
      • Solingen, Germany, 42699
        • Krankenhaus Bethanien gGmbH
  • Greece
      • Crete, Greece, 71500
        • Hospital of Heraklion (PAGNI)
      • Pátrai, Greece, 26504
        • Univ. Gen. Hosp. of Patras
  • Italy
      • Milan, Italy, 20123
        • Ospedale Classificato San Giuseppe
      • Padova, Italy, 35128
        • Azienda Ospedaliera Universitaria di Padova
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma, Italy, 00133
        • Pol. Universitario Tor Vergata
  • Japan
      • Fukui, Yoshida-gun, Japan, 910-1193
        • University of Fukui Hospital
      • Fukuoka, Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hokkaido, Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Hyogo, Himeji, Japan, 670-8520
        • National Hospital Organization Himeji Medical Center
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
      • Tokushima, Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Tokyo, Ota-ku, Japan, 143-8541
        • Toho University Omori Medical Center
      • Tokyo, Shinjuku-ku, Japan, 162-8655
        • National Center for Global Health and Medicine
  • Malaysia
      • Kajang, Malaysia, 43000
        • Hospital Sultan Idris Shah Serdang
      • Kuala Lumpur, Malaysia, 53000
        • Institut Perubatan Respiratori
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum-ROTTERDAM-50697
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • One Tree Hill, Auckland, New Zealand, 1051
        • Greenlane Clinical Centre
  • Norway
      • Bergen, Norway, N-5021
        • Haukeland Universitetssykehus
      • Lørenskog, Norway, 1478
        • Akershus Universitetssykehus HF
      • Oslo, Norway, N-0372
        • Oslo Universitetssykehus HF, Rikshospitalet
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
  • South Korea
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 01757
        • Inje University Sanggye Paik Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Galdakao, Spain, 48960
        • Hospital de Galdakao
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Oviedo, Spain, 33011
        • Hospital Central de Asturias
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Quirónsalud Madrid
  • Sweden
      • Lund, Sweden, 221 85
        • Skånes universitetssjukhus, Lund
      • Uppsala, Sweden, 752 37
        • CTC Clinical Trial Consultants AB
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital
      • Ratchatewi, Thailand, 10400
        • Ramathibodi Hospital
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • United Kingdom
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital, Wonford
      • Lancaster, United Kingdom, LA1 4RP
        • Royal Lancaster Infirmary
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Critical Care, Pulmonary and Sleep Associates
    • Florida
      • Kissimmee, Florida, United States, 34746
        • Clinical Research Specialists LLC - Kissimmee
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic, PC
    • Michigan
      • Warren, Michigan, United States, 48088
        • Advanced Pulmonary Research
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • Memorial Hospital Gulfport
    • New York
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Columbia University Medical Center-New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • New Bern, North Carolina, United States, 28562
        • Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
      • Winston-Salem, North Carolina, United States, 27103
        • Southeastern Research Center-Winston Salem-69289
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates of Central PA
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Lowcountry Lung and Critical Care
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
    • Texas
      • Edinburg, Texas, United States, 78539
        • A & A Research Consultants, LLC
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Pulmonary Associates of Richmond, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: IPF placebo

Participants with idiopathic pulmonary fibrosis (IPF) with clinically meaningful cough with background antifibrotic treatment on stable dose (for >12 weeks) or without antifibrotic treatment administered orally placebo matching BI 1839100 as tablets. Participants were planned to be treated for 12 weeks.
Drug: Placebo

Placebo
Experimental: IPF BI 1839100 low dose

Participants with idiopathic pulmonary fibrosis (IPF) with clinically meaningful cough with background antifibrotic treatment on stable dose (for >12 weeks) or without antifibrotic treatment administered orally low doses of BI 1839100 as tablets. Additionally, as needed, participants administered placebo tablets to maintain the blinding. Participants were planned to be treated for 12 weeks.
Drug: Placebo

Placebo

Drug: BI 1839100

BI 1839100
Experimental: IPF BI 1839100 medium dose

Participants with idiopathic pulmonary fibrosis (IPF) with clinically meaningful cough with background antifibrotic treatment on stable dose (for >12 weeks) or without antifibrotic treatment administered orally medium doses of BI 1839100 as tablets. Additionally, as needed, participants administered placebo tablets to maintain the blinding. Participants were planned to be treated for 12 weeks.
Drug: Placebo

Placebo

Drug: BI 1839100

BI 1839100
Experimental: IPF BI 1839100 high dose

Participants with idiopathic pulmonary fibrosis (IPF) with clinically meaningful cough with background antifibrotic treatment on stable dose (for >12 weeks) or without antifibrotic treatment administered orally high doses of BI 1839100 as tablets. Participants were planned to be treated for 12 weeks.
Drug: BI 1839100

BI 1839100

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4
Time Frame: At baseline (closest measurement prior to randomisation) and Week 4.

The raw Cough count (CC) over 24 h was standardised to CC per hour, and then log-transformed (natural log). The analysis was a restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM). The analysis included the fixed categorical effects of treatment, background antifibrotic (AF) treatment (Yes, No), and the fixed continuous effects of baseline. Visits were treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements. Intercurrent events were handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event. Adjusted estimates for relative change from baseline (reported here) were calculated by 100*(exp(diff)-1) where diff is the difference from baseline in log-transformed values.
At baseline (closest measurement prior to randomisation) and Week 4.
Phase IIb: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 12
Time Frame: The MMRM model incorporates CC from baseline (closest measurement prior to randomisation), Week 4, Week 8, and Week 12. The data represent the estimated mean change from baseline at Week 12.

The raw Cough count (CC) over 24 h was standardised to CC per hour, and then log-transformed (natural log). The analysis was a restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM). The analysis included the fixed categorical effects of treatment, background AF treatment (Yes, No), and the fixed continuous effects of baseline. Visits were treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements. Intercurrent events were handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event. Adjusted estimates for relative change from baseline (reported here) were calculated by 100*(exp(diff)-1) where diff is the difference from baseline in log-transformed values.
The MMRM model incorporates CC from baseline (closest measurement prior to randomisation), Week 4, Week 8, and Week 12. The data represent the estimated mean change from baseline at Week 12.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase IIa: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 4
Time Frame: At baseline (last measurement prior to the start of trial treatment) and at Week 4.

The Cough Severity NRS is a single-item patient reported outcome measure to assess cough severity on a 11-point numerical rating scale ranging from 0 (no cough) to 10 (worst possible cough) with a recall period of the past 7 days. Higher scores indicate higher severity of cough. The analysis was a REML based approach using a MMRM. The analysis included the fixed categorical effects of treatment, background AF treatment (Yes, No), and the fixed continuous effects of baseline. Visits were treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements. Intercurrent events were handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event.
At baseline (last measurement prior to the start of trial treatment) and at Week 4.
Phase IIa: Absolute Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score (Millimeter) at Week 4
Time Frame: At baseline (last measurement prior to the start of trial treatment) and at Week 4.

The Cough Severity VAS is a single-item patient reported outcome measure to assess cough severity with a visual analogue scale as response option and a recall period of the past 7 days. It is scored according to the distance between no cough (0) and the mark set by the participant on a line based on to the overall severity of the cough in the previous week, with the maximum being 100. Higher distance indicates higher severity of cough. The analysis was a REML based approach using a MMRM. The analysis included the fixed categorical effects of treatment, background AF treatment (Yes, No), and the fixed continuous effects of baseline. Visits were treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements. Intercurrent events were handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event.
At baseline (last measurement prior to the start of trial treatment) and at Week 4.
Phase IIb: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 12
Time Frame: The MMRM model incorporates values from baseline (last measurement prior to the start of trial treatment), Week 4, Week 8, and Week 12. The data represent the estimated mean change from baseline at Week 12.

The Cough Severity NRS is a single-item patient reported outcome measure to assess cough severity on a 11-point numerical rating scale ranging from 0 (no cough) to 10 (worst possible cough) with a recall period of the past 7 days. Higher scores indicate higher severity of cough. The analysis was a REML based approach using a MMRM. The analysis included the fixed categorical effects of treatment, background AF treatment (Yes, No), and the fixed continuous effects of baseline. Visits were treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements. Intercurrent events were handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event.
The MMRM model incorporates values from baseline (last measurement prior to the start of trial treatment), Week 4, Week 8, and Week 12. The data represent the estimated mean change from baseline at Week 12.
Phase IIb: Absolute Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score (Millimeter) at Week 12
Time Frame: The MMRM model incorporates values from baseline (last measurement prior to the start of trial treatment), Week 4, Week 8, and Week 12. The data represent the estimated mean change from baseline at Week 12.

The Cough Severity VAS is a single-item patient reported outcome measure to assess cough severity with a visual analogue scale as response option and a recall period of the past 7 days. It is scored according to the distance between no cough (0) and the mark set by the participant on a line based on to the overall severity of the cough in the previous week, with the maximum being 100. Higher distance indicates higher severity of cough. The analysis was a REML based approach using a MMRM. The analysis included the fixed categorical effects of treatment, background AF treatment (Yes, No), and the fixed continuous effects of baseline. Visits were treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements. Intercurrent events were handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event.
The MMRM model incorporates values from baseline (last measurement prior to the start of trial treatment), Week 4, Week 8, and Week 12. The data represent the estimated mean change from baseline at Week 12.
Phase IIb: Cough Responder Status, Defined as a ≥30% 24-h Cough Frequency Reduction (CC/h) From Baseline at Week 12
Time Frame: At baseline (last measurement prior to the start of trial treatment) and at Week 12.

The proportions of participants achieving a ≥30% 24-h cough frequency reduction (CC/h) at Week 12 is summarized. The % was calculated as: (number of participants with positive response)/(number of participants in group)*100. Confidence intervals were based on the Wilson method. Intercurrent events are handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event.
At baseline (last measurement prior to the start of trial treatment) and at Week 12.
Phase IIb: Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 12
Time Frame: The MMRM model incorporates values from baseline (last measurement prior to the start of trial treatment), Week 4, Week 8, and Week 12. The data represent the estimated mean change from baseline at Week 12.

FVC was assessed using standardised spirometry equipment. The analysis was a REML based approach using a MMRM. The analysis included the fixed categorical effects of treatment, background AF treatment (Yes, No), and the fixed continuous effects of baseline. Visits were treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements. Intercurrent events were handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event.
The MMRM model incorporates values from baseline (last measurement prior to the start of trial treatment), Week 4, Week 8, and Week 12. The data represent the estimated mean change from baseline at Week 12.
Phase IIb: Absolute Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score at Week 12
Time Frame: The MMRM model incorporates values from baseline (last measurement prior to the start of trial treatment), Week 4 and Week 12. The data represent the estimated mean change from baseline at Week 12.

The LCQ is a 19-item patient reported outcome measure that assesses the impact of cough on various aspects of Quality of life (QoL). It is divided into 3 domains (physical, social and psychological), each scored with a 7-point Likert response scale (1 to 7). The total score is calculated using the sum of the means of each subdomain, and ranges from 3 to 21. A higher score indicates better cough specific QoL. The analysis was a REML based approach using a MMRM. The analysis included the fixed categorical effects of treatment, background AF treatment (Yes, No), and the fixed continuous effects of baseline. Visits were treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements. Intercurrent events were handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event.
The MMRM model incorporates values from baseline (last measurement prior to the start of trial treatment), Week 4 and Week 12. The data represent the estimated mean change from baseline at Week 12.
Phase IIb: Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptom Cough Domain Score at Week 12
Time Frame: At baseline (last measurement prior to the start of trial treatment) and at Week 12.

The Symptom module domain of the L-PF questionnaire assesses 3 domains: dyspnea (items 1-12), cough (items 13-18), and fatigue (items 19-23) in the past 24 h. The module has a 5-point Likert scale (numeric rating scale) with varying response options. The Symptoms domain scores (dyspnoea, cough, and fatigue) are generated as a summary score, the mean of the dimension ratings multiplied by 100. The scores range from 0 to 100, with higher scores indicating a greater impairment. The analysis was a REML based approach using a MMRM. The analysis included the fixed categorical effects of treatment, background AF treatment (Yes, No), and the fixed continuous effects of baseline. Visits were treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements. Intercurrent events were handled with the treatment policy approach, which uses the value of the endpoint regardless of the occurrence of the intercurrent event.
At baseline (last measurement prior to the start of trial treatment) and at Week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1490-0004
  • 2023-510249-79-00 (Registry Identifier: CTIS)
  • U1111-1301-1311 (Registry Identifier: WHO Registry (ICTRP))
  • 2023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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