Uno studio per verificare se BI 1839100 migliora la tosse nelle persone con fibrosi polmonare idiopatica o fibrosi polmonare progressiva
Uno studio di fase IIa/IIb, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per l'individuazione della dose per esaminare l'efficacia e la sicurezza di BI 1839100 somministrato per via orale durante un periodo di trattamento di 12 settimane in pazienti con fibrosi polmonare idiopatica o fibrosi polmonare progressiva Con tosse clinicamente significativa
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Tasmania
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Launceston, Tasmania, Australia, 7250
- Launceston Respiratory & Sleep Centre
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Victoria
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Footscray, Victoria, Australia, 3011
- Lung Research Victoria
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Liège, Belgio, 4000
- CHR de la Citadelle
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Gordon & Leslie Diamond Health Care Centre (UBC)
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- Centre Hospitalier de l'Universite de Montreal (CHUM)
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Prague, Cechia, 140 59
- University Thomayer´s Hospital
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Changsha, Cina, 410011
- The Second Xiangya Hospital Of Central South University
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Chengdu, Cina, 610041
- West China Hospital, Sichuan University
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Chengdu, Cina, 610072
- People's Hospital of Sichuan Province
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Guangzhou, Cina, 510120
- First Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Cina, 310013
- Zhejiang Hospital
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Hefei, Cina, 230001
- Anhui Provincial Hospital
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Nanjing, Cina, 210008
- Nanjing Drum Tower Hospital
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Shanghai, Cina, 200433
- Shanghai Pulmonary Hospital
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Shenyang, Cina, 110000
- China Shenyang Chest Hospital
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Tianjin, Cina, 30052
- Tianjin Medical University General Hospital
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Xuzhou, Cina, 221009
- Affiliated Hospital, Xuzhou Medical college
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Seoul, Corea del Sud, 05505
- Asan Medical Center
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Seoul, Corea del Sud, 01757
- Inje University Sanggye Paik Hospital
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Odense, Danimarca, 5000
- Odense University Hospital
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Helsinki, Finlandia, 00029
- HYKS Keuhkosairauksien tutkimusyksikkö
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Oulu, Finlandia, 90220
- Oulun yliopistollinen keskussairaala
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Turku, Finlandia, 20520
- TYKS
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Angers, Francia, 49933
- HOP d'Angers
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Bobigny, Francia, 93000
- HOP Avicenne
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Caen, Francia, 14033
- HOP CHU Caen
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La Tronche, Francia, 38700
- HOP Michallon
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Nantes, Francia, 44093
- HOP Nord Laennec
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Tours, Francia, 37000
- HOP Bretonneau
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Aachen, Germania, 52074
- Universitätsklinikum Aachen, AöR
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Bamberg, Germania, 96049
- CIMS Studienzentrum Bamberg GmbH
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Essen, Germania, 45239
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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Freiburg im Breisgau, Germania, 79106
- Universitätsklinikum Freiburg
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Hanover, Germania, 30625
- Medizinische Hochschule Hannover
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Heidelberg, Germania, 69126
- Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
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Solingen, Germania, 42699
- Krankenhaus Bethanien gGmbH
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Fukui, Yoshida-gun, Giappone, 910-1193
- University of Fukui Hospital
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Fukuoka, Fukuoka, Giappone, 810-8563
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Fukuoka, Giappone, 812-8582
- Kyushu University Hospital
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Hokkaido, Sapporo, Giappone, 060-8543
- Sapporo Medical University Hospital
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Hyogo, Himeji, Giappone, 670-8520
- National Hospital Organization Himeji Medical Center
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Kanagawa, Yokohama, Giappone, 236-0051
- Kanagawa Cardiovascular and Respiratory Center
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Tokushima, Tokushima, Giappone, 770-8503
- Tokushima University Hospital
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Tokyo, Ota-ku, Giappone, 143-8541
- Toho University Omori Medical Center
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Tokyo, Shinjuku-ku, Giappone, 162-8655
- National Center for Global Health and Medicine
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Crete, Grecia, 71500
- Hospital of Heraklion (PAGNI)
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Pátrai, Grecia, 26504
- Univ. Gen. Hosp. of Patras
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Milan, Italia, 20123
- Ospedale Classificato San Giuseppe
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Padova, Italia, 35128
- Azienda Ospedaliera Universitaria di Padova
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Roma, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Roma, Italia, 00133
- Pol. Universitario Tor Vergata
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Kajang, Malaysia, 43000
- Hospital Sultan Idris Shah Serdang
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Kuala Lumpur, Malaysia, 53000
- Institut Perubatan Respiratori
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Bergen, Norvegia, N-5021
- Haukeland Universitetssykehus
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Lørenskog, Norvegia, 1478
- Akershus Universitetssykehus HF
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Oslo, Norvegia, N-0372
- Oslo Universitetssykehus HF, Rikshospitalet
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Christchurch, Nuova Zelanda, 8011
- Christchurch Hospital
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Hamilton, Nuova Zelanda, 3240
- Waikato Hospital
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One Tree Hill, Auckland, Nuova Zelanda, 1051
- Greenlane Clinical Centre
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Breda, Olanda, 4818 CK
- Amphia Ziekenhuis
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Rotterdam, Olanda, 3015 GD
- Erasmus Medisch Centrum-ROTTERDAM-50697
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Exeter, Regno Unito, EX2 5DW
- Royal Devon and Exeter Hospital, Wonford
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Lancaster, Regno Unito, LA1 4RP
- Royal Lancaster Infirmary
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London, Regno Unito, SW3 6NP
- Royal Brompton Hospital
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Manchester, Regno Unito, M23 9LT
- Wythenshawe Hospital
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Southampton, Regno Unito, SO16 6YD
- Southampton General Hospital
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Singapore, Singapore, 169608
- Singapore General Hospital
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Barcelona, Spagna, 08035
- Hospital Universitari Vall d'Hebron
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Galdakao, Spagna, 48960
- Hospital de Galdakao
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Málaga, Spagna, 29010
- Hospital Universitario Virgen de la Victoria
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Oviedo, Spagna, 33011
- Hospital Central de Asturias
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Pozuelo de Alarcón, Spagna, 28223
- Hospital Quirónsalud Madrid
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama at Birmingham
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Colorado
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Lakewood, Colorado, Stati Uniti, 80228
- Critical Care, Pulmonary and Sleep Associates
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Florida
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Kissimmee, Florida, Stati Uniti, 34746
- Clinical Research Specialists LLC - Kissimmee
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Iowa
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West Des Moines, Iowa, Stati Uniti, 50266
- The Iowa Clinic, PC
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Michigan
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Warren, Michigan, Stati Uniti, 48088
- Advanced Pulmonary Research
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Mississippi
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Gulfport, Mississippi, Stati Uniti, 39501
- Memorial Hospital Gulfport
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New York
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Mount Kisco, New York, Stati Uniti, 10549
- Northern Westchester Hospital
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New York, New York, Stati Uniti, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Stati Uniti, 10032
- Columbia University Medical Center-New York Presbyterian Hospital
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Medical Center
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New Bern, North Carolina, Stati Uniti, 28562
- Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
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Winston-Salem, North Carolina, Stati Uniti, 27103
- Southeastern Research Center-Winston Salem-69289
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Pennsylvania
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DuBois, Pennsylvania, Stati Uniti, 15801
- Clinical Research Associates of Central PA
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Philadelphia, Pennsylvania, Stati Uniti, 19140
- Temple University Hospital
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29406
- Lowcountry Lung and Critical Care
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Spartanburg, South Carolina, Stati Uniti, 29303
- Spartanburg Medical Research
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Texas
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Edinburg, Texas, Stati Uniti, 78539
- A & A Research Consultants, LLC
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Virginia
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Richmond, Virginia, Stati Uniti, 23230
- Pulmonary Associates of Richmond, Inc.
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Lund, Svezia, 221 85
- Skånes universitetssjukhus, Lund
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Uppsala, Svezia, 752 37
- CTC Clinical Trial Consultants AB
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Bangkok, Tailandia, 10330
- Chulalongkorn Hospital
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Khon Kaen, Tailandia, 40002
- Srinagarind Hospital
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Ratchatewi, Tailandia, 10400
- Ramathibodi Hospital
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Songkhla, Tailandia, 90110
- Songklanagarind Hospital
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Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria
For Idiopathic Pulmonary Fibrosis (IPF) cohort:
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Minimum age: 40 years
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Diagnosis of IPF
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Chronic cough (>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment)
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Cough Severity visual analogue scale (VAS) ≥30 mm at Visit 1 and Visit 2B
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Forced vital capacity (FVC) ≥45% of predicted normal at Visit 1
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Diffusing capacity of the lungs for carbon monoxide (DLCO) >25% of predicted normal at Visit 1
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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
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Patients aged ≥40 years when signing the informed consent
For Progressive Pulmonary Fibrosis (PPF) cohort:
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Minimum age: 18 years
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Diagnosis of PPF
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Chronic cough (>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment)
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Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B
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FVC ≥45% of predicted normal at Visit 1
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DLCO ≥25% of predicted normal at Visit 1
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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)
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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
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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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Comparatore placebo: 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. |
Placebo |
|
Sperimentale: 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. |
Placebo BI 1839100 |
|
Sperimentale: 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. |
Placebo BI 1839100 |
|
Sperimentale: 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. |
BI 1839100 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4
Lasso di tempo: At baseline (closest measurement prior to randomisation) and Week 4.
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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
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Phase IIa: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 4
Lasso di tempo: 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
Lasso di tempo: 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.
|
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Phase IIb: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 1490-0004
- 2023-510249-79-00 (Identificatore di registro: CTIS)
- U1111-1301-1311 (Identificatore di registro: WHO Registry (ICTRP))
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .