Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib

Study Overview
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Brief Summary
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Multi-center, non-interventional, prospective cohort study aiming to enroll 240 Idiopathic Pulmonary Fibrosis patients receiving treatment with nintedanib in a consecutive manner from 10-12 reference centers across Greece.

Official Title
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Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Nintedanib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥40 years of age. Patients that have signed Informed Consent Form. Treatment naive patients with an initial IPF diagnosis no more than 3 months prior to enrolment according to 2011 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines who are initiating treatment with nintedanib (as monotherapy for IPF) the latest on the enrollement day or have initiated treatment with nintedanib (as monotherapy for IPF) within the past 7 days prior to enrolment. Patients for whom the decision to prescribe therapy with nintedanib according to the locally approved product's Summary of Product Characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study. Patients that are able to read, understand and complete the study specific questionnaires. Exclusion Criteria: Treatment with nintedanib for more than 7 days prior to study enrolment. Patients receiving a combination therapy of nintedanib & pirfenidone for IPF. Patients that meet any of the contraindications to the administration of the study drug nintedanib according to the approved SmPC. Prior treatment with pirfenidone or other treatment for IPF. Participation in an interventional study. Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the initiation of therapy with nintedanib.

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Subjects with Idiopathic Pulmonary Fibrosis<br> | Drug: Nintedanib<br>* diagnosed IPF patients initiating treatment with nintedanib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Health Related Quality of Life (HRQoL) using SGRQ score | St. George's Respiratory Questionnaire (SGRQ) | upto 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of mean change from baseline of dyspnoea burden with modified Medical Research Council scale (mMRC) score | modified Medical Research Council scale (mMRC) | upto 12 months | 
| measurement of mean change form baseline to the follow up period of cough burden with Cough-Visual Analogue scale (cough-VAS) | Cough-Visual Analogue scale (cough-VAS) | upto 12 months | 
| Percentage of adhered patients to nintedanib treatment with Simplified Medication Adherence Questionnaire (SMAQ) | adapted for the treatment of idiopathic pulmonary fibrosis (IPF) | upto 52 weeks | 
| measurement of mean change of anxiety in IPF patients treated with nintedanib from baseline to follow up period via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire | Generalized Anxiety Disorder Screener (GAD-7) Questionnaire | upto 52 weeks | 
| Percentage of patients that use LTOT | Long Term Oxygen Treatment (LTOT) | upto 52 weeks |