Trial · NCT04702893
INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
NCT04702893, Completed, Boehringer Ingelheim; results first posted 2025-04-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation. Trials, record NCT04702893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04702893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
- NCT number
- NCT04702893
- Status
- Completed
- Enrollment
- 108 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Lung Diseases, Interstitial
- Interventions
- Nintedanib
- First posted
- 2021-01-11
- Last updated
- 2025-04-25
- Results first posted
- 2025-04-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Dyspnea Symptom Score | At baseline and at week 52±6. | The correlation between the change from baseline to week 52 (week 52 - baseline) in forced vital capacity (FVC) \[% predicted\] and change from baseline to week 52 (week 52 - baseline) in dyspnea symptom score was calculated using the Pearson's coefficient of correlation. The forced vital capacity measures the amount of air that can be forcefully exhaled from the lungs after a maximum inhalation. The dyspnea symptom score was measured using the living with pulmonary fibrosis questionnaire (L-PF). The L-PF contained a dyspnea symptom module with 12 items to assess the severity of shortness of breath, where the higher the score, the greater the impairment. The coefficient of correlation ranges from -1 to 1, indicating a negative association between the variables the closer it is to -1 and a positive association the closer it is to 1. |
| Primary | Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Cough Symptom Score | At baseline and at week 52±6. | The correlation between the change from baseline to week 52 (week 52 - baseline) in forced vital capacity (FVC) \[% predicted\] and change from baseline to week 52 (week 52 - baseline) in cough symptom score was calculated using the Pearson's coefficient of correlation. The forced vital capacity measures the amount of air that can be forcefully exhaled from the lungs after a maximum inhalation. The cough symptom score was measured using the living with pulmonary fibrosis questionnaire (L-PF). The L-PF contained a cough symptom module with 6 items to assess the severity of cough symptoms, where the higher the score, the more severe the cough. The coefficient of correlation ranges from -1 to 1, indicating a negative association between the variables the closer it is to -1 and a positive association the closer it is to 1. |
| Secondary | Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [mL] and Change From Baseline to Week 52 in Dyspnea Symptom Score | At baseline and at week 52±6. | The correlation between the change from baseline to week 52 (week 52 - baseline) in forced vital capacity (FVC) \[mL\] and change from baseline to week 52 (week 52 - baseline) in dyspnea symptom score was calculated using the Pearson's coefficient of correlation. The forced vital capacity measures the amount of air that can be forcefully exhaled from the lungs after a maximum inhalation. The dyspnea symptom score was measured using the living with pulmonary fibrosis questionnaire (L-PF). The L-PF contained a dyspnea symptom module with 12 items to assess the severity of shortness of breath, where the higher the score, the greater the impairment. The coefficient of correlation ranges from -1 to 1, indicating a negative association between the variables the closer it is to -1 and a positive association the closer it is to 1. |
| Secondary | Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [mL] and Change From Baseline to Week 52 in Cough Symptom Score | At baseline and at week 52±6. | The correlation between the change from baseline to week 52 (week 52 - baseline) in forced vital capacity (FVC) \[mL\] and change from baseline to week 52 (week 52 - baseline) in cough symptom score was calculated using the Pearson's coefficient of correlation. The forced vital capacity measures the amount of air that can be forcefully exhaled from the lungs after a maximum inhalation. The cough symptom score was measured using the living with pulmonary fibrosis questionnaire (L-PF). The L-PF contained a cough symptom module with 6 items to assess the severity of cough symptoms, where the higher the score, the more severe the cough. The coefficient of correlation ranges from -1 to 1, indicating a negative association between the variables the closer it is to -1 and a positive association the closer it is to 1. |
| Secondary | Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Cough Symptom Score [Points] at Week 52 | MMRM included measurements at week 13±6, week 26±6, week 39±6 and week 52±6. Change from baseline values at week 52±6 is reported. | This outcome measured the absolute change from baseline to week 52 in the cough symptom score, assessed by the living with pulmonary fibrosis questionnaire (L-PF). The L-PF includes a cough symptom module with 6 items to evaluate the severity of cough symptoms. Each item is scored on a scale of 0 to 4, with higher scores indicating more severe symptoms. The total cough symptom score was calculated using the formula: (sum of each individual score/24)\*100, ranging from 0 to 100, where the higher the score, the more severe the cough. Results were calculated as \[Week 52\] - \[Baseline\]. The analysis was performed using a mixed model for repeated measures (MMRM) with fixed independent effects for baseline value, visit, and baseline-by-visit interaction, and a random effect for each patient. Within-patient errors were represented using an unstructured variance-covariance structure. |
| Secondary | Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Dyspnea Symptom Score [Points] at Week 52 | MMRM included measurements at week 13±6, week 26±6, week 39±6 and week 52±6. Change from baseline values at week 52±6 is reported. | This outcome measured the absolute change from baseline to week 52 in the dyspnea symptom score, assessed by the living with pulmonary fibrosis questionnaire (L-PF). The L-PF includes a dyspnea symptom module with 12 items to evaluate the severity of dyspnea symptoms. Each item is scored on a scale of 0 to 5, with higher scores indicating more severe symptoms. The total dyspnea symptom score was calculated using the formula: (sum of each individual score/total score possible)\*100, ranging from 0 to 100, where the higher the score, the more severe the dyspnea. Results were calculated as \[Week 52\] - \[Baseline\]. The analysis was performed using a mixed model for repeated measures (MMRM) with fixed independent effects for baseline value, visit, and baseline-by-visit interaction, and a random effect for each patient. Within-patient errors were represented using an unstructured variance-covariance structure. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Dyspnea Symptom Score | At baseline and at week 52±6. | Treated set (TS): All patients with signed informed consent who received at least one dose of nintedanib. Patients with missing data were excluded from the analysis. | Pearson's coefficient of correlation | NUMBER |
| PRIMARY | Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Cough Symptom Score | At baseline and at week 52±6. | Treated set (TS): All patients with signed informed consent who received at least one dose of nintedanib. Patients with missing data were excluded from the analysis. | Pearson's coefficient of correlation | NUMBER |
| SECONDARY | Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [mL] and Change From Baseline to Week 52 in Dyspnea Symptom Score | At baseline and at week 52±6. | Treated set (TS): All patients with signed informed consent who received at least one dose of nintedanib. Patients with missing data were excluded from the analysis. | Pearson's coefficient of correlation | NUMBER |
| SECONDARY | Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [mL] and Change From Baseline to Week 52 in Cough Symptom Score | At baseline and at week 52±6. | Treated set (TS): All patients with signed informed consent who received at least one dose of nintedanib. Patients with missing data were excluded from the analysis. | Pearson's coefficient of correlation | NUMBER |
| SECONDARY | Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Cough Symptom Score [Points] at Week 52 | MMRM included measurements at week 13±6, week 26±6, week 39±6 and week 52±6. Change from baseline values at week 52±6 is reported. | Treated set (TS): All patients with signed informed consent who received at least one dose of nintedanib. Only patients with at least one post baseline value and baseline value were included in the analysis. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Dyspnea Symptom Score [Points] at Week 52 | MMRM included measurements at week 13±6, week 26±6, week 39±6 and week 52±6. Change from baseline values at week 52±6 is reported. | Treated set (TS): All patients with signed informed consent who received at least one dose of nintedanib. Only patients with at least one post baseline value and baseline value were included in the analysis. | Units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Dyspnea Symptom Score | Nintedanib-treated Patients | -0.2576 | 95% Confidence Interval -0.5333 to 0.0677 | Pearson's coefficient of correlation | |
| Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Cough Symptom Score | Nintedanib-treated Patients | -0.1093 | 95% Confidence Interval -0.4145 to 0.2180 | Pearson's coefficient of correlation | |
| Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [mL] and Change From Baseline to Week 52 in Dyspnea Symptom Score | Nintedanib-treated Patients | -0.2909 | 95% Confidence Interval -0.5587 to 0.0317 | Pearson's coefficient of correlation | |
| Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [mL] and Change From Baseline to Week 52 in Cough Symptom Score | Nintedanib-treated Patients | -0.1566 | 95% Confidence Interval -0.4536 to 0.1717 | Pearson's coefficient of correlation | |
| Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Cough Symptom Score [Points] at Week 52 | Nintedanib-treated Patients | 3.86 | Standard Error 3.28 | Units on a scale | |
| Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Dyspnea Symptom Score [Points] at Week 52 | Nintedanib-treated Patients | 6.26 | Standard Error 2.35 | Units on a scale |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nintedanib-treated Patients | 108 | |
| Overall Study | Treated | Nintedanib-treated Patients | 102 | |
| Overall Study | COMPLETED | Nintedanib-treated Patients | 71 | |
| Overall Study | NOT COMPLETED | Nintedanib-treated Patients | 37 |
Source ClinicalTrials.gov
Adverse events23
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Nintedanib-treated Patients | 42 | 102 | |
| other | Nausea | Gastrointestinal disorders | Nintedanib-treated Patients | 8 | 102 | |
| serious | Myocardial infarction | Cardiac disorders | Nintedanib-treated Patients | 1 | 102 | |
| serious | Death | General disorders | Nintedanib-treated Patients | 1 | 102 | |
| serious | Disease progression | General disorders | Nintedanib-treated Patients | 1 | 102 | |
| serious | General physical health deterioration | General disorders | Nintedanib-treated Patients | 1 | 102 | |
| serious | Sudden death | General disorders | Nintedanib-treated Patients | 1 | 102 | |
| serious | Hepatic cirrhosis | Hepatobiliary disorders | Nintedanib-treated Patients | 1 | 102 | |
| serious | Hypersensitivity | Immune system disorders | Nintedanib-treated Patients | 1 | 102 | |
| serious | Nasal abscess | Infections and infestations | Nintedanib-treated Patients | 1 | 102 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nintedanib-treated Patients | 10 | 102 |
| Total, other adverse events | Nintedanib-treated Patients | 45 | 102 |
| Total, serious adverse events | Nintedanib-treated Patients | 16 | 102 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT04702893/events?page=2