Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients

Study Overview
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Brief Summary
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The aim of this study is to identify correlations between change from the baseline at Month 24 in Forced Vital Capacity (FVC) (% predicted and mL) and change from the baseline at Month 24 in cough or dyspnoea scores [points] as measured in the living with pulmonary fibrosis questionnaire (L-PF) over 24 months of nintedanib treatment in patients with connective tissues disease-associated progressive fibrosing interstitial lung disease (CTD associated PF-ILD) under routine clinical practice conditions in Greece.

Official Title
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A Prospective, Observational Study on the Correlations Between Change in Lung Function and Change in Cough and Dyspnoea in Patients With Connective Tissue Disease-associated Progressive Fibrosing INTErstitial luNg diseaSE (CTD Associated PF-ILD) Treated With Nintedanib. The INTENSE Study

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: Age ≥18 years with a confirmed physician diagnosis of connective tissue disease (CTD) associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Have been prescribed nintedanib according to the local Summary of Product Characteristics (SmPC) and clinical judgment. Therapy with nintedanib must have been started for clinical reasons independently from the intended patient enrolment into the study at a maximum of 15 days before enrolment into the trial. Exclusion Criteria: Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nintedanib Patients at baseline with a known condition or reason that will result in withdrawal from the study before the 24-month time point Pregnancy or lactation

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 for CTD-associated PF-ILD patients in Greece<br>Connective Tissue Disease (CTD)-associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD) | 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 at Month 24 in forced vital capacity (FVC) [percentage (%) predicted] and change from baseline at Month 24 in dyspnoea symptom score [points] | 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. | At baseline and at month 24 | 
| Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [% predicted] and change from baseline at Month 24 in cough symptom score [points] |  | At baseline and at month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the change from baseline at Month 24 in forced vital capacity (FVC) [milliLitres (mL)] and change from baseline at Month 24 in dyspnoea symptom score [points] |  | At baseline and at month 24 | 
| Correlation between change from baseline at Month 24 in FVC [mL] and change from baseline at Month 24 in cough symptom score [points] |  | At baseline and at month 24 | 
| Correlation between baseline FVC [% pred] and change in dyspnoea symptom score [points] from baseline at month 24 |  | At baseline and at month 24 | 
| Correlation between baseline FVC [% pred] and change in cough symptom score [points] from baseline at month 24 |  | At baseline and at month 24 | 
| Absolute change from baseline in FVC [% pred] at month 24 |  | At baseline and at month 24 | 
| Absolute change from baseline in FVC [mL] at month 24 |  | At baseline and at month 24 | 
| Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score [points] at month 24 |  | At baseline and at month 24 | 
| Absolute change from baseline in L-PF cough symptom score [points] at month 24 |  | At baseline and at month 24 | 
| Change in total L-PF score [points] from baseline at month 24, or the end of the observation |  | At baseline and up to 24 months |