Clinical trial NCT06360094: A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
Official title: A Phase IIa/IIb, Randomised, Double Blind, Placebo-controlled, Parallel-group Dose-finding Study to Examine the Efficacy and Safety of BI 1839100 Administered Orally Over a 12-week Treatment Period in Patients With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis With Clinically Meaningful Cough
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h)
timeFrame: At baseline, at week 4
measure: IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h)
timeFrame: At baseline, at week 12
Secondary outcomes:
measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score
timeFrame: At baseline, at week 4
measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm)
timeFrame: At baseline, at week 4
measure: IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h)
timeFrame: At baseline, at week 12
measure: IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL)
timeFrame: At baseline, at week 12
measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score
timeFrame: At baseline, at week 12
measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm)
timeFrame: At baseline, at week 12
measure: IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score
timeFrame: At baseline, at week 12
measure: IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score
timeFrame: At baseline, at week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Lakewood
country: United States
facility: Critical Care, Pulmonary and Sleep Associates
state: Colorado
city: Kissimmee
country: United States
facility: Clinical Research Specialists LLC
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: West Des Moines
country: United States
facility: The Iowa Clinic, PC
state: Iowa
city: Warren
country: United States
facility: Advanced Pulmonary Research
state: Michigan
city: Gulfport
country: United States
facility: Memorial Hospital Gulfport
state: Mississippi
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center-New York Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center-Winston Salem-69289
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma-Oklahoma City-59108
state: Oklahoma
city: DuBois
country: United States
facility: Clinical Research Associates of Central PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Edinburg
country: United States
facility: A & A Research Consultants, LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: C.a.b.a
country: Argentina
facility: Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
city: Caba
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Caba
country: Argentina
facility: Centro de Investigación Clinica Belgrano
city: Caba
country: Argentina
facility: CEDIC - Centro de Investigacion Clinica
city: Capital Federal
country: Argentina
facility: Consultorios Médicos del Buen Ayre
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Camperdown, Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie University
state: New South Wales
city: Launceston
country: Australia
facility: Launceston Respiratory & Sleep Centre
state: Tasmania
city: Footscray
country: Australia
facility: Lung Research Victoria
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Institute for Respiratory Health
state: Western Australia
city: Graz
country: Austria
facility: Medical University of Graz State Hospital - University Hospital Graz
city: Krems
country: Austria
facility: Krems University Hospital
city: Linz
country: Austria
facility: Kepler Univ. Klinikum Linz
city: Linz
country: Austria
facility: Hospital Elisabethinen Linz
city: Vienna
country: Austria
facility: Clinic Floridsdorf
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen GmbH
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Gent
country: Belgium
facility: UNIV UZ Gent
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Liège
country: Belgium
facility: Liège - HOSP CHR de la Citadelle
city: Barra Mansa
country: Brazil
facility: Serviços Medicos Respirar Sul Fluminense
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu - UNESP
city: Goiania
country: Brazil
facility: CLARE - Clinica de Pneumologia
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
city: Sao Bernardo do Campo
country: Brazil
facility: Netspiro Clinica Medica Ltda - Respsono
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da FMUSP
city: Vancouver
country: Canada
facility: Gordon & Leslie Diamond Health Care Centre (UBC)
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital (Vancouver)
state: British Columbia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: CIC Mauricie Inc.
state: Quebec
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
city: Chengdu
country: China
facility: West China Hospital
city: Chengdu
country: China
facility: People's Hospital of Sichuan Province
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Hangzhou
country: China
facility: Zhejiang Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shenyang
country: China
facility: China Shenyang Chest Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xuzhou
country: China
facility: Affiliated Hospital, Xuzhou Medical college
city: Prague
country: Czechia
facility: Thomayer University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: HYKS Keuhkosairauksien tutkimusyksikkö
city: Oulu
country: Finland
facility: Oulun yliopistollinen keskussairaala
city: Turku
country: Finland
facility: TYKS
city: Angers
country: France
facility: HOP d'Angers
city: Bobigny
country: France
facility: HOP Avicenne
city: Caen
country: France
facility: HOP CHU Caen
city: La Tronche
country: France
facility: HOP Michallon
city: Lille
country: France
facility: INS Coeur Poumon
city: Marseille
country: France
facility: HOP Nord
city: Nantes
country: France
facility: HOP Nord Laennec
city: Paris
country: France
facility: HOP Bichat
city: Pessac
country: France
facility: HOP Haut-Lévêque
city: Rouen
country: France
facility: HOP Charles Nicolle
city: Tours
country: France
facility: HOP Bretonneau
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, AöR
city: Bamberg
country: Germany
facility: CIMS Studienzentrum Bamberg GmbH
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg, Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
city: Solingen
country: Germany
facility: Krankenhaus Bethanien gGmbH
city: Stralsund
country: Germany
facility: Helios Hanseklinikum Stralsund
city: Stuttgart
country: Germany
facility: Robert Bosch Gesellschaft für medizinische Forschung mbH
city: Würzburg
country: Germany
facility: Klinikum Würzburg Mitte gGmbH
city: Ioannina
country: Greece
facility: Univ. Gen. Hosp. of Ioannina
city: Patras
country: Greece
facility: Univ. Gen. Hosp. of Patras
city: Voutes
country: Greece
facility: Hospital of Heraklion (PAGNI)
city: Budapest
country: Hungary
facility: Koranyi National Institute For Pulmonolgy
city: Firenze
country: Italy
facility: A. O. Universitaria Careggi
city: Foggia
country: Italy
facility: Ospedale Colonnello D Avanzo
city: Forli'
country: Italy
facility: Ospedale G.B. Morgagni
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino
city: Milano
country: Italy
facility: Ospedale Classificato San Giuseppe
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Roma
country: Italy
facility: Pol. Universitario Tor Vergata
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
city: Aichi, Seto
country: Japan
facility: Tosei General Hospital
city: Chiba, Chiba
country: Japan
facility: Chiba University Hospital
city: Fukui, Yoshida-gun
country: Japan
facility: University of Fukui Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka, Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Hyogo, Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Kanagawa, Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Nagasaki, Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Osaka, Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Shizuoka, Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Tokushima, Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo, Mitaka
country: Japan
facility: Kyorin University Hospital
city: Tokyo, Ota-ku
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo, Shinjuku-ku
country: Japan
facility: National Center for Global Health and Medicine
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Kajang
country: Malaysia
facility: Hospital Sultan Idris Shah Serdang
city: Kuala Lumpur
country: Malaysia
facility: Institut Perubatan Respiratori
city: Kuching, Sarawak
country: Malaysia
facility: Sarawak General Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum-ROTTERDAM-50697
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: One Tree Hill, Auckland
country: New Zealand
facility: Greenlane Clinical Centre
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus HF
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Rikshospitalet
city: Bialystok
country: Poland
facility: University Clinical Hospital in Bialystok I
city: Swidnik
country: Poland
facility: Alergopneuma Medical Center
city: Warsaw
country: Poland
facility: Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Galdakao
country: Spain
facility: Hospital de Galdakao
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Quirónsalud Madrid
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Lund
country: Sweden
facility: Skånes universitetssjukhus, Lund
city: Uppsala
country: Sweden
facility: CTC Clinical Trial Consultants AB
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: TaoYuan
country: Taiwan
facility: Chang Gung Memorial Hospital(Linkou)
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Ratchatewi
country: Thailand
facility: Ramathibodi Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital, Wonford
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
References: