Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06360094
Registration number
NCT06360094
Ethics application status
Date submitted
8/04/2024
Date registered
11/04/2024
Date last updated
3/06/2025
Titles & IDs
Public title
A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2023-510249-79-00
Query!
Secondary ID [2]
0
0
1490-0004
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
0
0
Query!
Progressive Pulmonary Fibrosis
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Connective tissue diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - BI 1839100
Treatment: Drugs - Placebo
Placebo comparator: Phase IIa/IIb, IPF cohort: Placebo -
Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 low dose -
Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 medium dose -
Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 high dose -
Placebo comparator: Phase IIb, PPF cohort: Placebo -
Experimental: Phase IIb, PPF cohort: BI 1839100 high dose -
Treatment: Drugs: BI 1839100
BI 1839100
Treatment: Drugs: Placebo
Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
At baseline, at week 4
Query!
Primary outcome [2]
0
0
IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
At baseline, at week 12
Query!
Secondary outcome [1]
0
0
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score
Query!
Assessment method [1]
0
0
NRS: 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.
Query!
Timepoint [1]
0
0
At baseline, at week 4
Query!
Secondary outcome [2]
0
0
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm)
Query!
Assessment method [2]
0
0
VAS: the cough severity VAS is scored according to the distance between no cough (0) and the mark set by the participant, with higher distance indicating higher severity of cough.
Query!
Timepoint [2]
0
0
At baseline, at week 4
Query!
Secondary outcome [3]
0
0
IPF cohort - Phase IIb: Cough responder status, defined as a =30% reduction in 24-h cough frequency (CC/h)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
At baseline, at week 12
Query!
Secondary outcome [4]
0
0
IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL)
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
At baseline, at week 12
Query!
Secondary outcome [5]
0
0
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
At baseline, at week 12
Query!
Secondary outcome [6]
0
0
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm)
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
At baseline, at week 12
Query!
Secondary outcome [7]
0
0
IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score
Query!
Assessment method [7]
0
0
L-PF: the L-PF symptom module domain and total scores as well as the L-PF impact module total score ranges from 0 to 100, with higher scores indicating a greater impairment.
Query!
Timepoint [7]
0
0
At baseline, at week 12
Query!
Secondary outcome [8]
0
0
IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score
Query!
Assessment method [8]
0
0
LCQ: the total score ranges from 3 to 21. A higher score indicates better cough specific quality of life.
Query!
Timepoint [8]
0
0
At baseline, at week 12
Query!
Eligibility
Key inclusion 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/08/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
25/03/2026
Query!
Actual
Query!
Sample size
Target
230
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
Canberra Hospital - Canberra
Query!
Recruitment hospital [2]
0
0
Royal Prince Alfred Hospital - Camperdown, Sydney
Query!
Recruitment hospital [3]
0
0
Macquarie University - Macquarie Park
Query!
Recruitment hospital [4]
0
0
Launceston Respiratory & Sleep Centre - Launceston
Query!
Recruitment hospital [5]
0
0
Lung Research Victoria - Footscray
Query!
Recruitment hospital [6]
0
0
Austin Hospital - Heidelberg
Query!
Recruitment hospital [7]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [8]
0
0
Institute for Respiratory Health - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2605 - Canberra
Query!
Recruitment postcode(s) [2]
0
0
2050 - Camperdown, Sydney
Query!
Recruitment postcode(s) [3]
0
0
2109 - Macquarie Park
Query!
Recruitment postcode(s) [4]
0
0
7250 - Launceston
Query!
Recruitment postcode(s) [5]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [6]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [7]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [8]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Iowa
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Mississippi
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Nevada
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oklahoma
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
South Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Utah
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Virginia
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
C.a.b.a
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Caba
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Capital Federal
Query!
Country [20]
0
0
Austria
Query!
State/province [20]
0
0
Graz
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Krems
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Linz
Query!
Country [23]
0
0
Austria
Query!
State/province [23]
0
0
Vienna
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Wels
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Bruxelles
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Gent
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Liège
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Barra Mansa
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Botucatu
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Goiania
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Porto Alegre
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Sao Bernardo do Campo
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Sao Paulo
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
São Paulo
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
British Columbia
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Ontario
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Quebec
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Beijing
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Changsha
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Chengdu
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Guangzhou
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Hangzhou
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Hefei
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Nanjing
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Shanghai
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Shenyang
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Tianjin
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Xuzhou
Query!
Country [49]
0
0
Czechia
Query!
State/province [49]
0
0
Prague
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
Odense
Query!
Country [51]
0
0
Finland
Query!
State/province [51]
0
0
Helsinki
Query!
Country [52]
0
0
Finland
Query!
State/province [52]
0
0
Oulu
Query!
Country [53]
0
0
Finland
Query!
State/province [53]
0
0
Turku
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Angers
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Bobigny
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Caen
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
La Tronche
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Lille
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Marseille
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Nantes
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Paris
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Pessac
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Rouen
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Tours
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Aachen
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Bamberg
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Berlin
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Essen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Freiburg
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Hamburg
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Hannover
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Heidelberg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Solingen
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Stralsund
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Stuttgart
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Würzburg
Query!
Country [77]
0
0
Greece
Query!
State/province [77]
0
0
Ioannina
Query!
Country [78]
0
0
Greece
Query!
State/province [78]
0
0
Patras
Query!
Country [79]
0
0
Greece
Query!
State/province [79]
0
0
Voutes
Query!
Country [80]
0
0
Hungary
Query!
State/province [80]
0
0
Budapest
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Firenze
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Foggia
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Forli'
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Genova
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Milano
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Padova
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Roma
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Aichi, Seto
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Chiba, Chiba
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Fukui, Yoshida-gun
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Fukuoka, Fukuoka
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Hokkaido, Sapporo
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Hyogo, Himeji
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Kanagawa, Yokohama
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Nagasaki, Nagasaki
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Osaka, Sakai
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Shizuoka, Hamamatsu
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Tokushima, Tokushima
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Tokyo, Mitaka
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Tokyo, Ota-ku
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Tokyo, Shinjuku-ku
Query!
Country [102]
0
0
Korea, Republic of
Query!
State/province [102]
0
0
Bucheon
Query!
Country [103]
0
0
Korea, Republic of
Query!
State/province [103]
0
0
Busan
Query!
Country [104]
0
0
Korea, Republic of
Query!
State/province [104]
0
0
Seongnam
Query!
Country [105]
0
0
Korea, Republic of
Query!
State/province [105]
0
0
Seoul
Query!
Country [106]
0
0
Malaysia
Query!
State/province [106]
0
0
Kajang
Query!
Country [107]
0
0
Malaysia
Query!
State/province [107]
0
0
Kuala Lumpur
Query!
Country [108]
0
0
Malaysia
Query!
State/province [108]
0
0
Kuching, Sarawak
Query!
Country [109]
0
0
Netherlands
Query!
State/province [109]
0
0
Breda
Query!
Country [110]
0
0
Netherlands
Query!
State/province [110]
0
0
Rotterdam
Query!
Country [111]
0
0
New Zealand
Query!
State/province [111]
0
0
Christchurch
Query!
Country [112]
0
0
New Zealand
Query!
State/province [112]
0
0
Hamilton
Query!
Country [113]
0
0
New Zealand
Query!
State/province [113]
0
0
One Tree Hill, Auckland
Query!
Country [114]
0
0
Norway
Query!
State/province [114]
0
0
Bergen
Query!
Country [115]
0
0
Norway
Query!
State/province [115]
0
0
Lørenskog
Query!
Country [116]
0
0
Norway
Query!
State/province [116]
0
0
Oslo
Query!
Country [117]
0
0
Poland
Query!
State/province [117]
0
0
Bialystok
Query!
Country [118]
0
0
Poland
Query!
State/province [118]
0
0
Swidnik
Query!
Country [119]
0
0
Poland
Query!
State/province [119]
0
0
Warsaw
Query!
Country [120]
0
0
Singapore
Query!
State/province [120]
0
0
Singapore
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
Alicante
Query!
Country [122]
0
0
Spain
Query!
State/province [122]
0
0
Barcelona
Query!
Country [123]
0
0
Spain
Query!
State/province [123]
0
0
Galdakao
Query!
Country [124]
0
0
Spain
Query!
State/province [124]
0
0
L'Hospitalet de Llobregat
Query!
Country [125]
0
0
Spain
Query!
State/province [125]
0
0
Madrid
Query!
Country [126]
0
0
Spain
Query!
State/province [126]
0
0
Malaga
Query!
Country [127]
0
0
Spain
Query!
State/province [127]
0
0
Oviedo
Query!
Country [128]
0
0
Spain
Query!
State/province [128]
0
0
Pozuelo de Alarcón
Query!
Country [129]
0
0
Spain
Query!
State/province [129]
0
0
Santander
Query!
Country [130]
0
0
Spain
Query!
State/province [130]
0
0
Santiago de Compostela
Query!
Country [131]
0
0
Spain
Query!
State/province [131]
0
0
Sevilla
Query!
Country [132]
0
0
Sweden
Query!
State/province [132]
0
0
Lund
Query!
Country [133]
0
0
Sweden
Query!
State/province [133]
0
0
Uppsala
Query!
Country [134]
0
0
Taiwan
Query!
State/province [134]
0
0
Kaohsiung
Query!
Country [135]
0
0
Taiwan
Query!
State/province [135]
0
0
Taichung
Query!
Country [136]
0
0
Taiwan
Query!
State/province [136]
0
0
Taipei
Query!
Country [137]
0
0
Taiwan
Query!
State/province [137]
0
0
TaoYuan
Query!
Country [138]
0
0
Thailand
Query!
State/province [138]
0
0
Bangkok
Query!
Country [139]
0
0
Thailand
Query!
State/province [139]
0
0
Khon Kaen
Query!
Country [140]
0
0
Thailand
Query!
State/province [140]
0
0
Ratchatewi
Query!
Country [141]
0
0
Thailand
Query!
State/province [141]
0
0
Songkhla
Query!
Country [142]
0
0
United Kingdom
Query!
State/province [142]
0
0
Cottingham
Query!
Country [143]
0
0
United Kingdom
Query!
State/province [143]
0
0
Exeter
Query!
Country [144]
0
0
United Kingdom
Query!
State/province [144]
0
0
Lancaster
Query!
Country [145]
0
0
United Kingdom
Query!
State/province [145]
0
0
London
Query!
Country [146]
0
0
United Kingdom
Query!
State/province [146]
0
0
Manchester
Query!
Country [147]
0
0
United Kingdom
Query!
State/province [147]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06360094
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-800-243-0127
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06360094
Download to PDF