CompletedNot Applicable

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

Bulgaria, Czechia158 participantsStarted 2023-02-08

Plain-language summary

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)).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 s…

What they're measuring

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

Timeframe: 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

Timeframe: Up to week 52

Trial details

NCT IDNCT05151640

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-05

View on ClinicalTrials.gov More Lung Diseases, Interstitial trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: Up to week 52