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En studie för att testa om BI 1839100 förbättrar hosta hos personer med idiopatisk lungfibros eller progressiv lungfibros

28 augusti 2026 uppdaterad av: Boehringer Ingelheim

En fas IIa/IIb, randomiserad, dubbelblind, placebokontrollerad, parallellgruppsdossökningsstudie för att undersöka effektiviteten och säkerheten av BI 1839100 administrerat oralt under en 12-veckors behandlingsperiod hos patienter med idiopatisk lungfibros eller progressiv lungfibros Med kliniskt meningsfull hosta

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

85

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
    • Tasmania
      • Launceston, Tasmania, Australien, 7250
        • Launceston Respiratory & Sleep Centre
    • Victoria
      • Footscray, Victoria, Australien, 3011
        • Lung Research Victoria
  • Belgien
      • Liège, Belgien, 4000
        • CHR de la Citadelle
  • Danmark
      • Odense, Danmark, 5000
        • Odense University Hospital
  • Finland
      • Helsinki, Finland, 00029
        • HYKS Keuhkosairauksien tutkimusyksikkö
      • Oulu, Finland, 90220
        • Oulun yliopistollinen keskussairaala
      • Turku, Finland, 20520
        • TYKS
  • Frankrike
      • Angers, Frankrike, 49933
        • HOP d'Angers
      • Bobigny, Frankrike, 93000
        • HOP Avicenne
      • Caen, Frankrike, 14033
        • HOP CHU Caen
      • La Tronche, Frankrike, 38700
        • HOP Michallon
      • Nantes, Frankrike, 44093
        • HOP Nord Laennec
      • Tours, Frankrike, 37000
        • HOP Bretonneau
  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35294
        • University of Alabama at Birmingham
    • Colorado
      • Lakewood, Colorado, Förenta staterna, 80228
        • Critical Care, Pulmonary and Sleep Associates
    • Florida
      • Kissimmee, Florida, Förenta staterna, 34746
        • Clinical Research Specialists LLC - Kissimmee
    • Iowa
      • West Des Moines, Iowa, Förenta staterna, 50266
        • The Iowa Clinic, PC
    • Michigan
      • Warren, Michigan, Förenta staterna, 48088
        • Advanced Pulmonary Research
    • Mississippi
      • Gulfport, Mississippi, Förenta staterna, 39501
        • Memorial Hospital Gulfport
    • New York
      • Mount Kisco, New York, Förenta staterna, 10549
        • Northern Westchester Hospital
      • New York, New York, Förenta staterna, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Förenta staterna, 10032
        • Columbia University Medical Center-New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke University Medical Center
      • New Bern, North Carolina, Förenta staterna, 28562
        • Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
      • Winston-Salem, North Carolina, Förenta staterna, 27103
        • Southeastern Research Center-Winston Salem-69289
    • Pennsylvania
      • DuBois, Pennsylvania, Förenta staterna, 15801
        • Clinical Research Associates of Central PA
      • Philadelphia, Pennsylvania, Förenta staterna, 19140
        • Temple University Hospital
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29406
        • Lowcountry Lung and Critical Care
      • Spartanburg, South Carolina, Förenta staterna, 29303
        • Spartanburg Medical Research
    • Texas
      • Edinburg, Texas, Förenta staterna, 78539
        • A & A Research Consultants, LLC
    • Virginia
      • Richmond, Virginia, Förenta staterna, 23230
        • Pulmonary Associates of Richmond, Inc.
  • Grekland
      • Crete, Grekland, 71500
        • Hospital of Heraklion (PAGNI)
      • Pátrai, Grekland, 26504
        • Univ. Gen. Hosp. of Patras
  • Italien
      • Milan, Italien, 20123
        • Ospedale Classificato San Giuseppe
      • Padova, Italien, 35128
        • Azienda Ospedaliera Universitaria di Padova
      • Roma, Italien, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma, Italien, 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
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre (UBC)
    • Ontario
      • Hamilton, Ontario, Kanada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
    • Quebec
      • Montreal, Quebec, Kanada, H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • Kina
      • Changsha, Kina, 410011
        • The Second Xiangya Hospital Of Central South University
      • Chengdu, Kina, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Kina, 610072
        • People's Hospital of Sichuan Province
      • Guangzhou, Kina, 510120
        • First Affiliated Hospital of Guangzhou Medical University
      • Hangzhou, Kina, 310013
        • Zhejiang Hospital
      • Hefei, Kina, 230001
        • Anhui Provincial Hospital
      • Nanjing, Kina, 210008
        • Nanjing Drum Tower Hospital
      • Shanghai, Kina, 200433
        • Shanghai Pulmonary Hospital
      • Shenyang, Kina, 110000
        • China Shenyang Chest Hospital
      • Tianjin, Kina, 30052
        • Tianjin Medical University General Hospital
      • Xuzhou, Kina, 221009
        • Affiliated Hospital, Xuzhou Medical college
  • Malaysia
      • Kajang, Malaysia, 43000
        • Hospital Sultan Idris Shah Serdang
      • Kuala Lumpur, Malaysia, 53000
        • Institut Perubatan Respiratori
  • Nederländerna
      • Breda, Nederländerna, 4818 CK
        • Amphia Ziekenhuis
      • Rotterdam, Nederländerna, 3015 GD
        • Erasmus Medisch Centrum-ROTTERDAM-50697
  • Norge
      • Bergen, Norge, N-5021
        • Haukeland Universitetssykehus
      • Lørenskog, Norge, 1478
        • Akershus Universitetssykehus HF
      • Oslo, Norge, N-0372
        • Oslo Universitetssykehus HF, Rikshospitalet
  • Nya Zeeland
      • Christchurch, Nya Zeeland, 8011
        • Christchurch Hospital
      • Hamilton, Nya Zeeland, 3240
        • Waikato Hospital
      • One Tree Hill, Auckland, Nya Zeeland, 1051
        • Greenlane Clinical Centre
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Universitari Vall d'Hebron
      • Galdakao, Spanien, 48960
        • Hospital de Galdakao
      • Málaga, Spanien, 29010
        • Hospital Universitario Virgen de la Victoria
      • Oviedo, Spanien, 33011
        • Hospital Central de Asturias
      • Pozuelo de Alarcón, Spanien, 28223
        • Hospital Quirónsalud Madrid
  • Storbritannien
      • Exeter, Storbritannien, EX2 5DW
        • Royal Devon and Exeter Hospital, Wonford
      • Lancaster, Storbritannien, LA1 4RP
        • Royal Lancaster Infirmary
      • London, Storbritannien, SW3 6NP
        • Royal Brompton Hospital
      • Manchester, Storbritannien, M23 9LT
        • Wythenshawe Hospital
      • Southampton, Storbritannien, SO16 6YD
        • Southampton General Hospital
  • Sverige
      • Lund, Sverige, 221 85
        • Skånes universitetssjukhus, Lund
      • Uppsala, Sverige, 752 37
        • CTC Clinical Trial Consultants AB
  • Sydkorea
      • Seoul, Sydkorea, 05505
        • Asan Medical Center
      • Seoul, Sydkorea, 01757
        • Inje University Sanggye Paik Hospital
  • 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
  • Tjeckien
      • Prague, Tjeckien, 140 59
        • University Thomayer´s Hospital
  • Tyskland
      • Aachen, Tyskland, 52074
        • Universitätsklinikum Aachen, AöR
      • Bamberg, Tyskland, 96049
        • CIMS Studienzentrum Bamberg GmbH
      • Essen, Tyskland, 45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Freiburg im Breisgau, Tyskland, 79106
        • Universitätsklinikum Freiburg
      • Hanover, Tyskland, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Tyskland, 69126
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
      • Solingen, Tyskland, 42699
        • Krankenhaus Bethanien gGmbH

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: 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.
Läkemedel: Placebo

Placebo
Experimentell: 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.
Läkemedel: Placebo

Placebo

Läkemedel: BI 1839100

BI 1839100
Experimentell: 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.
Läkemedel: Placebo

Placebo

Läkemedel: BI 1839100

BI 1839100
Experimentell: 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.
Läkemedel: BI 1839100

BI 1839100

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4
Tidsram: 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
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Phase IIa: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 4
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

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Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 augusti 2024

Primärt slutförande (Faktisk)

2 september 2025

Avslutad studie (Faktisk)

2 september 2025

Studieregistreringsdatum

Först inskickad

8 april 2024

Först inskickad som uppfyllde QC-kriterierna

8 april 2024

Första postat (Faktisk)

11 april 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1490-0004
  • 2023-510249-79-00 (Registeridentifierare: CTIS)
  • U1111-1301-1311 (Registeridentifierare: WHO Registry (ICTRP))
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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