Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Tutkimus, jolla testataan, parantaako BI 1839100 yskää ihmisillä, joilla on idiopaattinen keuhkofibroosi tai progressiivinen keuhkofibroosi

perjantai 28. elokuuta 2026 päivittänyt: Boehringer Ingelheim

Vaiheen IIa/IIb, satunnaistettu, kaksoissokko, lumekontrolloitu, rinnakkaisryhmän annoksenmääritystutkimus, jossa tutkitaan BI 1839100:n tehoa ja turvallisuutta suun kautta 12 viikon hoitojakson aikana potilailla, joilla on idiopaattinen keuhkofibroosi tai progressiivinen keuhkofibroosi Kliinisesti merkityksellisen yskän kanssa

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.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

85

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
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.
Lääke: Placebo

Placebo
Kokeellinen: 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.
Lääke: Placebo

Placebo

Lääke: BI 1839100

BI 1839100
Kokeellinen: 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.
Lääke: Placebo

Placebo

Lääke: BI 1839100

BI 1839100
Kokeellinen: 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.
Lääke: BI 1839100

BI 1839100

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4
Aikaikkuna: 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
Aikaikkuna: 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.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Phase IIa: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 4
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.

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Sponsori

Boehringer Ingelheim

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Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Keskiviikko 28. elokuuta 2024

Ensisijainen valmistuminen (Todellinen)

Tiistai 2. syyskuuta 2025

Opintojen valmistuminen (Todellinen)

Tiistai 2. syyskuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 8. huhtikuuta 2024

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 8. huhtikuuta 2024

Ensimmäinen Lähetetty (Todellinen)

Torstai 11. huhtikuuta 2024

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 23. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 28. elokuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 1490-0004
  • 2023-510249-79-00 (Rekisterin tunniste: CTIS)
  • U1111-1301-1311 (Rekisterin tunniste: WHO Registry (ICTRP))
  • 2023 (Yhdysvaltain NIH-apuraha/sopimus)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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-jaon aikakehys

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-jaon käyttöoikeuskriteerit

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-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • CSR

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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