INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease 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 study is to investigate the correlation between changes from baseline to 52 weeks in Forced Vital Capacity (FVC) [% pred.] and changes from baseline to 52 weeks in dyspnea score [points] or cough score [points] as measured with the living with pulmonary fibrosis (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) Initiation of nintedanib as first antifibrotic therapy according to physician´s decision which has been made as part of routine care prior to and independent of study inclusion 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 Interstitial lung disease (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 |
| --- | --- |
| Nintedanib treatment group<br> | Drug: Nintedanib<br>* Nintedanib<br>|

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) [% pred.] and change from baseline to week 52 in dyspnea symptom score | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of health related quality of life (HRQoL) over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | Up to week 52 | 
| Correlation between change from baseline to week 52 in Forced vital capacity (FVC) [% pred.] and change from baseline to week 52 in cough symptom score | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | Up to week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between change from baseline to week 52 in Forced vital capacity (FVC) [millilitres mL] and change from baseline to week 52 in dyspnea symptom score | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | Up to week 52 | 
| Correlation between change from baseline to week 52 in Forced vital capacity (FVC) [millilitres mL] and change from baseline to week 52 in cough symptom score | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | Up to week 52 | 
| Absolute change from baseline in living with pulmonary fibrosis (L-PF) cough symptom score [points] at week 52 | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | At week 52 | 
| Absolute change from baseline in living with pulmonary fibrosis (L-PF) dyspnea symptom score [points] at week 52 | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | At week 52 |