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

Boehringer Ingelheim

Status

Terminated

Conditions

Lung Diseases, Interstitial

Treatments

Drug: Nintedanib

Study type

Observational

Funder types

Industry

Identifiers

NCT05503030

1199-0501

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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