protocolSection identificationModule nctId: NCT06360094, orgStudyIdInfo id: 1490-0004, secondaryIdInfos id: 2023-510249-79-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1301-1311, type: REGISTRY, domain: WHO Registry (ICTRP), briefTitle: A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-27, primaryCompletionDateStruct date: 2025-07-21, completionDateStruct date: 2025-08-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, conditions: Progressive Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: BI 1839100, interventions name: Placebo, outcomesModule primaryOutcomes measure: IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h), primaryOutcomes measure: IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h), secondaryOutcomes measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score, secondaryOutcomes measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm), secondaryOutcomes measure: IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h), secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL), secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score, secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm), secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score, secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False