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

Lung Diseases, Interstitial Clinical Trial

Official title:

A Prospective, Observational Study on the Correlations Between Change in Lung Function and Change in Cough and Dyspnoea in Patients With Connective Tissue Disease-associated Progressive Fibrosing INTErstitial luNg diseaSE (CTD Associated PF-ILD) Treated With Nintedanib. The "INTENSE" Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503030
• Other study ID #: 1199-0501
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Dyspnea
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• Nintedanib
Nintedanib

Locations

Country	Name	City	State
Greece	General Hospital KAT	Athens
Greece	General Hospital of Athens "G. Gennimatas"	Athens
Greece	General Hospital of Athens "Ippokrateio"	Athens
Greece	General Hospital of Athens "Laiko"	Athens
Greece	Private physician Dr. Goni	Athens
Greece	Private physician Dr. Karageorgas	Athens
Greece	Private physician Dr. Katsifis	Athens
Greece	University General Hospital ATTIKON	Athens
Greece	University General Hospital of Heraklion	Heraklion
Greece	Private physician Dr. Georgiadis	Ioannina
Greece	University General Hospital of Ioannina	Ioannina
Greece	Private physician Prof. Sakkas	Larisa
Greece	University General Hospital of Larisa	Larisa
Greece	Private physician Dr. Iliadou	Nea Smirni, Athens
Greece	Private physician Dr Bounas	Patra
Greece	University General Hospital of Patras	Patra
Greece	General Hospital of Thessaloniki "Hippokration"	Thessaloniki
Greece	Private physician Dr. Triantafyllidou	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline and at month 24
Primary	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	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
Secondary	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
Secondary	Correlation between baseline FVC [% pred] and change in dyspnoea symptom score [points] from baseline at month 24		At baseline and at month 24
Secondary	Correlation between baseline FVC [% pred] and change in cough symptom score [points] from baseline at month 24		At baseline and at month 24
Secondary	Absolute change from baseline in FVC [% pred] at month 24		At baseline and at month 24
Secondary	Absolute change from baseline in FVC [mL] at month 24		At baseline and at month 24
Secondary	Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score [points] at month 24		At baseline and at month 24
Secondary	Absolute change from baseline in L-PF cough symptom score [points] at month 24		At baseline and at month 24
Secondary	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

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