Active — Not RecruitingNot Applicable

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

Greece88 participantsStarted 2022-12-21

Plain-language summary

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.

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: * 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

What they're measuring

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]

Timeframe: At baseline and at month 24

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

Timeframe: At baseline and at month 24

Trial details

NCT IDNCT05503030

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-05-11

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

Timeframe: At baseline and at month 24

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

Timeframe: At baseline and at month 24