Clinical trial NCT05503030: Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-08-16
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.


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

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: 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]
timeFrame: At baseline and at month 24
measure: Correlation between change from baseline at Month 24 in FVC [mL] and change from baseline at Month 24 in cough symptom score [points]
timeFrame: At baseline and at month 24
measure: Correlation between baseline FVC [% pred] and change in dyspnoea symptom score [points] from baseline at month 24
timeFrame: At baseline and at month 24
measure: Correlation between baseline FVC [% pred] and change in cough symptom score [points] from baseline at month 24
timeFrame: At baseline and at month 24
measure: Absolute change from baseline in FVC [% pred] at month 24
timeFrame: At baseline and at month 24
measure: Absolute change from baseline in FVC [mL] at month 24
timeFrame: At baseline and at month 24
measure: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score [points] at month 24
timeFrame: At baseline and at month 24
measure: Absolute change from baseline in L-PF cough symptom score [points] at month 24
timeFrame: At baseline and at month 24
measure: Change in total L-PF score [points] from baseline at month 24, or the end of the observation
timeFrame: At baseline and up to 24 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Private physician
city: Athens
country: Greece
facility: Private physician
city: Athens
country: Greece
facility: "G. Gennimatas" General Hospital of Athens
city: Athens
country: Greece
facility: "Ippokration" General Hospital of Athens
city: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Athens
country: Greece
facility: Private physician
city: Athens
country: Greece
facility: "ATTIKON" University General Hospital
city: Athens
country: Greece
facility: "KAT" General Hospital
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Ioannina
country: Greece
facility: Private physician
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Larisa
country: Greece
facility: Private physician
city: Larisa
country: Greece
facility: University General Hospital of Larisa
city: Nea Smirni, Athens
country: Greece
facility: Private physician
city: Patra
country: Greece
facility: Private physician
city: Patra
country: Greece
facility: University General Hospital of Patra
city: Thessaloniki
country: Greece
facility: Private physician
city: Thessaloniki
country: Greece
facility: "Hippokration" General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: "G. Papanikolaou" General University of Thessaloniki
city: Thessaloniki
country: Greece
facility: Clinic "Agios Loukas"
Study officials:
References: