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一项测试 BI 1839100 能否改善特发性肺纤维化或进行性肺纤维化患者咳嗽的研究

2026年8月28日 更新者：Boehringer Ingelheim

一项 IIa/IIb 期、随机、双盲、安慰剂对照、平行组剂量探索研究，旨在检验 BI 1839100 在 12 周治疗期内口服给药对特发性肺纤维化或进行性肺纤维化患者的疗效和安全性具有临床意义的咳嗽

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.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

85

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：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.
药品：Placebo

Placebo
实验性的：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.
药品：Placebo

Placebo

药品：BI 1839100

BI 1839100
实验性的：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.
药品：Placebo

Placebo

药品：BI 1839100

BI 1839100
实验性的：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.
药品：BI 1839100

BI 1839100

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4
大体时间：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
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
Phase IIa: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 4
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boehringer Ingelheim

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年8月28日

初级完成 (实际的)

2025年9月2日

研究完成 (实际的)

2025年9月2日

研究注册日期

首次提交

2024年4月8日

首先提交符合 QC 标准的

2024年4月8日

首次发布 (实际的)

2024年4月11日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年8月28日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1490-0004
  • 2023-510249-79-00 (注册表标识符：CTIS)
  • U1111-1301-1311 (注册表标识符：WHO Registry (ICTRP))
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

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 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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