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

Study Overview
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Brief Summary
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The primary objective of this observational study is to investigate the correlation between changes from baseline at 52 weeks in forced vital capacity (FVC) and changes from baseline at 52 weeks in dyspnea score points or cough score points as measured with the pulmonary fibrosis questionnaire (L-PF) questionnaire over 52 weeks of nintedanib treatment in patients suffering from chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype (excluding idiopathic pulmonary fibrosis (IPF)).

Official Title
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Prospective Observational Investigation of Possible Correlations Between Change in FVC and Change in Cough or Dyspnea Scores Using the Living With Pulmonary Fibrosis Questionnaire (L-PF) Between Baseline and After Approximately 52 Weeks of Nintedanib Treatment in Patients Suffering From Chronic Fibrosing ILD With a Progressive Phenotype

Conditions
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Lung Diseases, Interstitial

Intervention / Treatment
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* Drug: Nintedanib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years at Visit 1 Subjects must be contractually capable and mentally able to understand and follow the instructions of the study personnel Physician's diagnosis of chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype, except idiopathic pulmonary fibrosis (IPF) Treatment with nintedanib in INREAL will be the first and only prescription of any antifibrotic treatment for each individual patient within this observational study after a physician's decision being made for this treatment option earlier Outpatients not currently hospitalized with a life expectancy > 12 months per investigator's assessment Written informed consent prior to study participation Current forced vital capacity (FVC) measurement (taken within the last 3 months) available in the patient file Women of childbearing potential must take appropriate precautions against getting pregnant during the intake of nintedanib Exclusion Criteria: Patients with contraindications according to Summary of Product Characteristics (SmPC) Prior use of any antifibrotic treatment Lack of informed consent Pregnant or lactating females Any physician diagnosed exacerbation of ILD in the patient's history file, irrespective of time since event Current diagnosis of lung cancer Respiratory failure (pH < 7,35 and/ or respiratory rate > 30/min) in the patient's history Participation in a parallel interventional clinical trial Patients being spouse or lateral relatives to the second degree or economically dependent from the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic fibrosing interstitial lung disease (ILD) patients with a progressive phenotype<br> | Drug: Nintedanib<br>* Nintedanib<br>* Other names: Ofev®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The dyspnea symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF dyspnea symptom score ranges from 0 to 92; the higher the score, the greater the impairment. | baseline, week 52 | 
| Correlation between change from baseline to week 52 in FVC [% predicted] and change from baseline to week 52 in cough symptom score | The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment. | baseline, week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between change from baseline to week 52 in FVC [milliliter (ml)] and change from baseline to week 52 in dyspnea symptom score | The dyspnea symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF dyspnea symptom score ranges from 0 to 92; the higher the score, the greater the impairment. | baseline, week 52 | 
| Correlation between change from baseline to week 52 in FVC [ml] and change from baseline to week 52 in cough symptom score | The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment. | baseline, week 52 | 
| Absolute change from baseline in L-PF cough symptom score at week 52 | The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment. | baseline, week 52 | 
| Absolute change from baseline in L-PF dyspnea symptom score at week 52 | The dyspnea symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF dyspnea symptom score ranges from 0 to 92; the higher the score, the greater the impairment. | baseline, week 52 |