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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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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)).

Eligibility

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

Study details

Lung Diseases, Interstitial

NCT05151640

Boehringer Ingelheim

15 June 2024

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