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

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Description

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.

Targeted Conditions

Study Overview

Start Date
November 1, 2022
Completion Date
December 30, 2026
Enrollment
120
Date Posted
August 16, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Private physician Dr. Goni
Athens 10676, Greece

Private physician Dr. Katsifis
Athens 11362, Greece

General Hospital of Athens "Ippokrateio"
Athens 11527, Greece

General Hospital of Athens "Laiko"
Athens 11527, Greece

Private physician Dr. Karageorgas
Athens 11634, Greece

University General Hospital ATTIKON
Athens 12462, Greece

General Hospital KAT
Athens 14561, Greece

University General Hospital of Heraklion
Heraklion 71003, Greece

Private physician Dr. Georgiadis
Ioannina 45332, Greece

Private physician Prof. Sakkas
Larisa 41222, Greece

University General Hospital of Larisa
Larisa 41334, Greece

Private physician Dr. Iliadou
Nea Smirni, Athens 17121, Greece

General Hospital of Thessaloniki "Hippokration"
Thessaloniki 54642, Greece

Eligibility

Study Population
Patients with physician-diagnosed interstitial lung disease (ILD) must fulfil at least one of the following criteria for progressive fibrosing (PF)-ILD within the previous period and up to two years before the screening, despite standard treatment to treat ILD: Clinically significant decline in forced vital capacity (FVC) percentage (%) predicted based on a relative decline of ≥ 10% The marginal decline in FVC % predicted based on a relative decline of ≥ 5-< 10% combined with worsening respiratory symptoms The marginal decline in FVC % predicted based on a relative decline of ≥ 5-< 10% combined with increasing extent of fibrotic changes on chest imaging Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging All patients will need to be treatment naïve concerning antifibrotic treatments (i.e., nintedanib or pirfenidone) before initiating nintedanib. Enrolment period will be 24 months, and each participant will be observed for 24 months.
Minimum Age (years)
18
Eligibility Criteria
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

Study Contact Info

Study Contact Name
Boehringer Ingelheim
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05503030