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 Ingelheim88 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lung Diseases, Interstitial

Interventions

NintedanibDRUG

Nintedanib

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Private physician

Athens, Greece

Private physician

Athens, Greece

"G. Gennimatas" General Hospital of Athens

Athens, Greece

"Ippokration" General Hospital of Athens

Athens, Greece

"Laiko" General Hospital of Athens

Athens, Greece

Private physician

Athens, Greece

"ATTIKON" University General Hospital

Athens, Greece

"KAT" General Hospital

Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

University General Hospital of Heraklion

Heraklion, Greece

...and 10 more locations

Outcomes

Primary Outcomes

Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [percentage (%) predicted] and change from baseline at Month 24 in dyspnoea symptom score [points]

The "living with pulmonary fibrosis" (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of health related quality of life (HRQoL) over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. Items in both modules have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely". Overall scores range from 0 to 100, with higher numbers indicating a greater impairment.