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

Boehringer Ingelheim

Status: Active, not recruiting

Conditions: Lung Diseases, Interstitial

Treatments: Drug: Nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT05151640

1199-0467

Details and patient eligibility

About

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)).

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 1 patient group

Nintedanib treatment group

Treatment:

Drug: Nintedanib