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BI 1839100が特発性肺線維症または進行性肺線維症患者の咳を改善するかどうかを試験する研究

2026年8月28日 更新者：Boehringer Ingelheim

特発性肺線維症または進行性肺線維症の患者を対象に、12週間の治療期間にわたって経口投与されたBI 1839100の有効性と安全性を調べるための第IIa/IIb相、無作為化、二重盲検、プラセボ対照、並行群間用量設定研究臨床的に意味のある咳の場合

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.

調査の概要

状態

終了しました

条件

介入・治療

研究の種類

介入

入学 (実際)

85

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35294
        • University of Alabama at Birmingham
    • Colorado
      • Lakewood、Colorado、アメリカ、80228
        • Critical Care, Pulmonary and Sleep Associates
    • Florida
      • Kissimmee、Florida、アメリカ、34746
        • Clinical Research Specialists LLC - Kissimmee
    • Iowa
      • West Des Moines、Iowa、アメリカ、50266
        • The Iowa Clinic, PC
    • Michigan
      • Warren、Michigan、アメリカ、48088
        • Advanced Pulmonary Research
    • Mississippi
      • Gulfport、Mississippi、アメリカ、39501
        • Memorial Hospital Gulfport
    • New York
      • Mount Kisco、New York、アメリカ、10549
        • Northern Westchester Hospital
      • New York、New York、アメリカ、10029
        • Icahn School of Medicine at Mount Sinai
      • New York、New York、アメリカ、10032
        • Columbia University Medical Center-New York Presbyterian Hospital
    • North Carolina
      • Durham、North Carolina、アメリカ、27710
        • Duke University Medical Center
      • New Bern、North Carolina、アメリカ、28562
        • Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
      • Winston-Salem、North Carolina、アメリカ、27103
        • Southeastern Research Center-Winston Salem-69289
    • Pennsylvania
      • DuBois、Pennsylvania、アメリカ、15801
        • Clinical Research Associates of Central PA
      • Philadelphia、Pennsylvania、アメリカ、19140
        • Temple University Hospital
    • South Carolina
      • Charleston、South Carolina、アメリカ、29406
        • Lowcountry Lung and Critical Care
      • Spartanburg、South Carolina、アメリカ、29303
        • Spartanburg Medical Research
    • Texas
      • Edinburg、Texas、アメリカ、78539
        • A & A Research Consultants, LLC
    • Virginia
      • Richmond、Virginia、アメリカ、23230
        • Pulmonary Associates of Richmond, Inc.
  • イギリス
      • Exeter、イギリス、EX2 5DW
        • Royal Devon and Exeter Hospital, Wonford
      • Lancaster、イギリス、LA1 4RP
        • Royal Lancaster Infirmary
      • London、イギリス、SW3 6NP
        • Royal Brompton Hospital
      • Manchester、イギリス、M23 9LT
        • Wythenshawe Hospital
      • Southampton、イギリス、SO16 6YD
        • Southampton General Hospital
  • イタリア
      • Milan、イタリア、20123
        • Ospedale Classificato San Giuseppe
      • Padova、イタリア、35128
        • Azienda Ospedaliera Universitaria di Padova
      • Roma、イタリア、00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma、イタリア、00133
        • Pol. Universitario Tor Vergata
  • オランダ
      • Breda、オランダ、4818 CK
        • Amphia Ziekenhuis
      • Rotterdam、オランダ、3015 GD
        • Erasmus Medisch Centrum-ROTTERDAM-50697
  • オーストラリア
    • Tasmania
      • Launceston、Tasmania、オーストラリア、7250
        • Launceston Respiratory & Sleep Centre
    • Victoria
      • Footscray、Victoria、オーストラリア、3011
        • Lung Research Victoria
  • カナダ
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre (UBC)
    • Ontario
      • Hamilton、Ontario、カナダ、L8N 4A6
        • St. Joseph's Healthcare Hamilton
    • Quebec
      • Montreal、Quebec、カナダ、H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • ギリシャ
      • Crete、ギリシャ、71500
        • Hospital of Heraklion (PAGNI)
      • Pátrai、ギリシャ、26504
        • Univ. Gen. Hosp. of Patras
  • シンガポール
      • Singapore、シンガポール、169608
        • Singapore General Hospital
  • スウェーデン
      • Lund、スウェーデン、221 85
        • Skånes universitetssjukhus, Lund
      • Uppsala、スウェーデン、752 37
        • CTC Clinical Trial Consultants AB
  • スペイン
      • Barcelona、スペイン、08035
        • Hospital Universitari Vall d'Hebron
      • Galdakao、スペイン、48960
        • Hospital de Galdakao
      • Málaga、スペイン、29010
        • Hospital Universitario Virgen de la Victoria
      • Oviedo、スペイン、33011
        • Hospital Central de Asturias
      • Pozuelo de Alarcón、スペイン、28223
        • Hospital Quirónsalud Madrid
  • タイ
      • Bangkok、タイ、10330
        • Chulalongkorn Hospital
      • Khon Kaen、タイ、40002
        • Srinagarind Hospital
      • Ratchatewi、タイ、10400
        • Ramathibodi Hospital
      • Songkhla、タイ、90110
        • Songklanagarind Hospital
  • チェコ
      • Prague、チェコ、140 59
        • University Thomayer´s Hospital
  • デンマーク
      • Odense、デンマーク、5000
        • Odense University Hospital
  • ドイツ
      • Aachen、ドイツ、52074
        • Universitätsklinikum Aachen, AöR
      • Bamberg、ドイツ、96049
        • CIMS Studienzentrum Bamberg GmbH
      • Essen、ドイツ、45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Freiburg im Breisgau、ドイツ、79106
        • Universitätsklinikum Freiburg
      • Hanover、ドイツ、30625
        • Medizinische Hochschule Hannover
      • Heidelberg、ドイツ、69126
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
      • Solingen、ドイツ、42699
        • Krankenhaus Bethanien gGmbH
  • ニュージーランド
      • Christchurch、ニュージーランド、8011
        • Christchurch Hospital
      • Hamilton、ニュージーランド、3240
        • Waikato Hospital
      • One Tree Hill, Auckland、ニュージーランド、1051
        • Greenlane Clinical Centre
  • ノルウェー
      • Bergen、ノルウェー、N-5021
        • Haukeland Universitetssykehus
      • Lørenskog、ノルウェー、1478
        • Akershus Universitetssykehus HF
      • Oslo、ノルウェー、N-0372
        • Oslo Universitetssykehus HF, Rikshospitalet
  • フィンランド
      • Helsinki、フィンランド、00029
        • HYKS Keuhkosairauksien tutkimusyksikkö
      • Oulu、フィンランド、90220
        • Oulun yliopistollinen keskussairaala
      • Turku、フィンランド、20520
        • TYKS
  • フランス
      • Angers、フランス、49933
        • HOP d'Angers
      • Bobigny、フランス、93000
        • HOP Avicenne
      • Caen、フランス、14033
        • HOP CHU Caen
      • La Tronche、フランス、38700
        • HOP Michallon
      • Nantes、フランス、44093
        • HOP Nord Laennec
      • Tours、フランス、37000
        • HOP Bretonneau
  • ベルギー
      • Liège、ベルギー、4000
        • CHR de la Citadelle
  • マレーシア
      • Kajang、マレーシア、43000
        • Hospital Sultan Idris Shah Serdang
      • Kuala Lumpur、マレーシア、53000
        • Institut Perubatan Respiratori
  • 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
  • 台湾
      • Kaohsiung City、台湾、807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung、台湾、40705
        • Taichung Veterans General Hospital
  • 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
  • 韓国
      • Seoul、韓国、05505
        • Asan Medical Center
      • Seoul、韓国、01757
        • Inje University Sanggye Paik Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：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.
薬：Placebo

Placebo
実験的：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.
薬：Placebo

Placebo

薬：BI 1839100

BI 1839100
実験的：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.
薬：Placebo

Placebo

薬：BI 1839100

BI 1839100
実験的：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.
薬：BI 1839100

BI 1839100

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4
時間枠：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
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Phase IIa: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 4
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Boehringer Ingelheim

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年8月28日

一次修了 (実際)

2025年9月2日

研究の完了 (実際)

2025年9月2日

試験登録日

最初に提出

2024年4月8日

QC基準を満たした最初の提出物

2024年4月8日

最初の投稿 (実際)

2024年4月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月23日

QC基準を満たした最後の更新が送信されました

2026年8月28日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 1490-0004
  • 2023-510249-79-00 (レジストリ識別子：CTIS)
  • U1111-1301-1311 (レジストリ識別子：WHO Registry (ICTRP))
  • 2023 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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