Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
- Registration Number
- NCT05503030
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 87
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Nintedanib for CTD-associated PF-ILD patients in Greece Nintedanib Connective Tissue Disease (CTD)-associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
- Primary Outcome Measures
Name Time Method 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] At baseline and at month 24 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.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] At baseline and at month 24
- Secondary Outcome Measures
Name Time Method Correlation between the change from baseline at Month 24 in forced vital capacity (FVC) [milliLitres (mL)] and change from baseline at Month 24 in dyspnoea symptom score [points] At baseline and at month 24 Correlation between baseline FVC [% pred] and change in cough symptom score [points] from baseline at month 24 At baseline and at month 24 Absolute change from baseline in FVC [% pred] at month 24 At baseline and at month 24 Absolute change from baseline in FVC [mL] at month 24 At baseline and at month 24 Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score [points] at month 24 At baseline and at month 24 Change in total L-PF score [points] from baseline at month 24, or the end of the observation At baseline and up to 24 months Correlation between baseline FVC [% pred] and change in dyspnoea symptom score [points] from baseline at month 24 At baseline and at month 24 Absolute change from baseline in L-PF cough symptom score [points] at month 24 At baseline and at month 24 Correlation between change from baseline at Month 24 in FVC [mL] and change from baseline at Month 24 in cough symptom score [points] At baseline and at month 24
Trial Locations
- Locations (13)
Clinic "Agios Loukas"
🇬🇷Thessaloniki, Greece
Private physician
🇬🇷Thessaloniki, Greece
"G. Gennimatas" General Hospital of Athens
🇬🇷Athens, Greece
"Ippokration" General Hospital of Athens
🇬🇷Athens, Greece
"Laiko" General Hospital of Athens
🇬🇷Athens, Greece
"ATTIKON" University General Hospital
🇬🇷Athens, Greece
"KAT" General Hospital
🇬🇷Athens, Greece
University General Hospital of Heraklion
🇬🇷Heraklion, Greece
University General Hospital of Ioannina
🇬🇷Ioannina, Greece
University General Hospital of Larisa
🇬🇷Larisa, Greece
University General Hospital of Patra
🇬🇷Patra, Greece
"Hippokration" General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
"G. Papanikolaou" General University of Thessaloniki
🇬🇷Thessaloniki, Greece