A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

StatusTerminated
PhasePhase 2
Started

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Record History

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  1. Notable Results posted: Sep 23, 2026 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (8)
    • Study sites revised (99)
    • Study arms: 6 to 4
  2. Minor Study sites revised (99)v35
  3. Minor Study sites: 98 to 99v34
  4. Stopped Trial status: Active, Not Recruiting to Terminated Sponsor's reason: Sponsor decision
    • Study sites: 171 to 98
    • Primary completion date changed from estimate of Jul 20, 2026 to Sep 2, 2025
    • Study completion date changed from estimate of Jul 27, 2026 to Sep 2, 2025
    v33
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 230 to confirmed 85
    • Study sites: 179 to 171
    v32
Show 30 earlier versionsHide 30 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv31
  2. Minor Site details revised at 3 of 179 sitesv30
  3. Minor Study sites: 180 to 179v29
  4. Minor Primary completion date: Mar 18, 2026 to Jul 20, 2026
    • Study completion date: Mar 25, 2026 to Jul 27, 2026
    • Study sites revised (180)
    v28
  5. Notable Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 180 of 180 sites
    v27
  6. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 180 of 180 sites
    v26
  7. Minor Site details revised at 12 of 180 sitesv25
  8. Minor Site details revised at 1 of 180 sitesv24
  9. Minor Site details revised at 19 of 180 sitesv23
  10. Minor Study sites: 102 to 180v22
  11. Minor Study sites: 99 to 102v21
  12. Minor Study sites: 93 to 99v20
  13. Minor Study sites: 85 to 93v19
  14. Minor Study sites: 78 to 85v18
  15. Minor Study sites: 82 to 78v17
  16. Minor Study sites: 92 to 82v16
  17. Minor Study sites: 83 to 92v15
  18. Minor Study sites: 92 to 83v14
  19. Minor Study sites: 121 to 92v13
  20. Notable Primary completion date: Jul 21, 2025 to Mar 18, 2026
    • Study sites: 117 to 121
    • Study completion date: Aug 6, 2025 to Mar 25, 2026
    v12
  21. Minor Study sites: 114 to 117v11
  22. Minor Study sites: 69 to 114
    • Start date: Aug 20, 2024 to Aug 28, 2024
    • Eligibility criteria expanded, about 36 words
    v10
  23. Minor Study sites: 68 to 69v9
  24. Minor Study sites: 45 to 68v8
  25. Minor Study sites: 27 to 45v7
  26. Minor Study sites: 20 to 27v6
  27. Minor Study sites: 8 to 20v5
  28. Minor Study sites: 1 to 8v4
  29. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  30. Minor Start date: Jul 27, 2024 to Aug 20, 2024v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06360094
Lead Sponsor Boehringer Ingelheim
Conditions
(from sponsor)
Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Related terms Idiopathic Pulmonary Fibrosis
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov