A Phase 2 interventional study of BI 1839100 and Placebo in Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, sponsored by Boehringer Ingelheim. Terminated at 99 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
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.
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's enrollment of 85 is above the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
For Idiopathic Pulmonary Fibrosis (IPF) cohort:
Patients may be either:
For Progressive Pulmonary Fibrosis (PPF) cohort:
Patients may be either:
Exclusion criteria for IPF and PPF cohorts:
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.
Drug: 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 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.
Drug: BI 1839100 · Drug: 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 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.
Drug: BI 1839100 · Drug: 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 high doses of BI 1839100 as tablets. Participants were planned to be treated for 12 weeks.
Drug: BI 1839100
BI 1839100
Placebo
Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4
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.
Time frame: 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
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.
Time frame: 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.
Phase IIa: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score 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.
Time frame: 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
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.
Time frame: At baseline (last measurement prior to the start of trial treatment) and at Week 4.
Phase IIb: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score 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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: At baseline (last measurement prior to the start of trial treatment) and at Week 12.
This was a randomised, placebo-controlled, double-blind, parallel-group, multi-centre, multi-national, 12-week clinical trial with a seamless Phase IIa/IIb design (idiopathic pulmonary fibrosis cohort) with an exploratory 4-week progressive pulmonary fibrosis cohort (not enrolled due to trial termination) to investigate the efficacy and safety of BI 1839100.
| Milestone | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Started | 14 | 14 | 28 | 29 |
| Completed | 14 | 12 | 26 | 27 |
| Not completed | 0 | 2 | 2 | 2 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 |
| Withdrew: Perceived lack of efficacy | 0 | 1 | 0 | 0 |
| Withdrew: Burden of study procedures | 0 | 0 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 1 |
| Withdrew: Other than listed | 0 | 1 | 0 | 0 |
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.
| Percentage of change in CC/h | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4 | -39.48 (-56.63 to -15.55) | -20.97 (-43.03 to 9.62) | -30.13 (-44.65 to -11.79) | -25.93 (-41.00 to -7.01) |
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.
| Percentage of change in CC/h | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIb: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 12 | -63.22 (-74.83 to -46.25) | -40.89 (-59.02 to -14.72) | -52.38 (-63.43 to -37.98) | -12.57 (-32.07 to 12.53) |
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.
| Units on a scale | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIa: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 4 | -1.47 (-2.48 to -0.45) | -1.50 (-2.52 to -0.47) | -1.03 (-1.76 to -0.31) | -0.98 (-1.70 to -0.27) |
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.
| Units on a scale | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIa: Absolute Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score (Millimeter) at Week 4 | -16.33 (-27.23 to -5.44) | -15.02 (-25.90 to -4.14) | -12.31 (-20.12 to -4.51) | -14.03 (-21.63 to -6.42) |
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.
| Units on a scale | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIb: Absolute Change From Baseline in Cough Severity Numerical Rating Scale (NRS) Score at Week 12 | -2.65 (-3.82 to -1.48) | -1.86 (-3.06 to -0.66) | -1.69 (-2.55 to -0.84) | -0.98 (-1.81 to -0.14) |
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.
| Units on a scale | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIb: Absolute Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score (Millimeter) at Week 12 | -25.62 (-38.05 to -13.19) | -15.64 (-28.28 to -3.00) | -19.08 (-28.23 to -9.93) | -14.62 (-23.48 to -5.76) |
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.
| Percentage of participants | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIb: Cough Responder Status, Defined as a ≥30% 24-h Cough Frequency Reduction (CC/h) From Baseline at Week 12 | 80.0 (49.0 to 94.3) | 63.6 (35.4 to 84.8) | 71.4 (50.0 to 86.2) | 39.1 (22.2 to 59.2) |
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.
| Milliliter (mL) | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIb: Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 12 | 1.20 (-137.76 to 140.16) | -82.89 (-225.24 to 59.46) | -41.28 (-141.45 to 58.89) | -89.82 (-188.61 to 8.98) |
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.
| Units on a scale | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIb: Absolute Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score at Week 12 | 0.51 (-0.03 to 1.06) | 0.53 (0.00 to 1.06) | 0.29 (-0.09 to 0.66) | 0.26 (-0.10 to 0.62) |
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.
| Units on a scale | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Phase IIb: Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptom Cough Domain Score at Week 12 | -16.5 (-26.46 to -6.54) | -10.34 (-20.38 to -0.31) | -12.73 (-19.83 to -5.64) | -10.63 (-17.41 to -3.86) |
Collected over From first drug administration until last drug administration, up to approximately 13 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IPF BI 1839100 Low Dose | 0/14 (0%) | 0/14 (0%) | 9/14 (64.3%) |
| IPF BI 1839100 Medium Dose | 0/14 (0%) | 3/14 (21.4%) | 8/14 (57.1%) |
| IPF BI 1839100 High Dose | 0/28 (0%) | 3/28 (10.7%) | 18/28 (64.3%) |
| IPF Placebo | 0/29 (0%) | 4/29 (13.8%) | 14/29 (48.3%) |
| Event | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| Arteriosclerosis coronary arteryCardiac disorders | 0/14 | 1/14 | 0/28 | 0/29 |
| VertigoEar and labyrinth disorders | 0/14 | 1/14 | 0/28 | 0/29 |
| Pneumonia klebsiellaInfections and infestations | 0/14 | 1/14 | 0/28 | 0/29 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/14 | 1/14 | 0/28 | 0/29 |
| Condition aggravatedGeneral disorders | 0/14 | 0/14 | 1/28 | 1/29 |
| PneumoniaInfections and infestations | 0/14 | 0/14 | 1/28 | 0/29 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/14 | 0/14 | 1/28 | 0/29 |
| Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 0/14 | 0/14 | 1/28 | 0/29 |
| Electrocardiogram T wave inversionInvestigations | 0/14 | 0/14 | 0/28 | 1/29 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/14 | 0/14 | 0/28 | 1/29 |
| Event | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo |
|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/14 | 1/14 | 5/28 | 3/29 |
| DyspepsiaGastrointestinal disorders | 2/14 | 1/14 | 1/28 | 1/29 |
| Decreased appetiteMetabolism and nutrition disorders | 0/14 | 2/14 | 0/28 | 1/29 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/14 | 0/14 | 4/28 | 1/29 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/14 | 0/14 | 4/28 | 2/29 |
| PruritusSkin and subcutaneous tissue disorders | 2/14 | 0/14 | 0/28 | 2/29 |
| FatigueGeneral disorders | 0/14 | 0/14 | 3/28 | 2/29 |
| HeadacheNervous system disorders | 1/14 | 0/14 | 1/28 | 3/29 |
| Arteriosclerosis coronary arteryCardiac disorders | 0/14 | 1/14 | 0/28 | 0/29 |
| Abdominal painGastrointestinal disorders | 0/14 | 1/14 | 0/28 | 0/29 |
Full Analysis Set (FAS): all randomised participants who received at least 1 dose of trial medication and had both a baseline visit (i.e. pretreatment) and at least 1 post baseline assessment after receiving at least 1 dose of trial medication. Participants were analysed according to the treatment group to which they were randomised.
| Age, Continuous(Years) | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo | Total |
|---|---|---|---|---|---|
| Mean | 71.1 ± 6.1 | 69.1 ± 8.8 | 72.6 ± 7.3 | 71.7 ± 5.9 | 71.5 ± 6.9 |
| Sex: Female, Male(Participants) | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo | Total |
|---|---|---|---|---|---|
| Female | 2 | 3 | 10 | 6 | 21 |
| Male | 12 | 11 | 18 | 23 | 64 |
| Ethnicity (NIH/OMB)(Participants) | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 | 0 | 2 |
| Not Hispanic or Latino | 14 | 13 | 27 | 29 | 83 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 6 | 8 | 8 | 12 | 34 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 0 | 1 |
| White | 8 | 6 | 18 | 16 | 48 |
| More than one race | 0 | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| 24-hour cough frequency (CC/h)(Cough count per hour) | IPF BI 1839100 Low Dose | IPF BI 1839100 Medium Dose | IPF BI 1839100 High Dose | IPF Placebo | Total |
|---|---|---|---|---|---|
| Mean | 35.613 ± 30.294 | 22.224 ± 22.392 | 30.451 ± 27.495 | 30.243 ± 29.481 | 29.875 ± 27.708 |
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Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Idiopathic Pulmonary Fibrosis→