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

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

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 Overview

• Status: Completed
• Conditions: Lung Diseases, Interstitial
• Intervention / Treatment: Drug: Nintedanib

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11527
    • "Laiko" General Hospital of Athens
  • Athens, Greece, 10676
    • Private physician
  • Athens, Greece, 11362
    • Private physician
  • Athens, Greece, 11527
    • "G. Gennimatas" General Hospital of Athens
  • Athens, Greece, 11527
    • "Ippokration" General Hospital of Athens
  • Athens, Greece, 11634
    • Private physician
  • Athens, Greece, 12462
    • "ATTIKON" University General Hospital
  • Athens, Greece, 14561
    • "KAT" General Hospital
  • Heraklion, Greece, 71110
    • University General Hospital of Heraklion
  • Heraklion, Greece, 71003
    • University General Hospital of Heraklion
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina
  • Ioannina, Greece, 45332
    • Private physician
  • Larissa, Greece, 41222
    • Private physician
  • Larissa, Greece, 41334
    • University General Hospital of Larisa
  • Nea Smirni, Athens, Greece, 17121
    • Private physician
  • Pátrai, Greece, 26504
    • Private physician
  • Pátrai, Greece, 26504
    • University General Hospital of Patra
  • Thessaloniki, Greece, 54642
    • "Hippokration" General Hospital of Thessaloniki
  • Thessaloniki, Greece, 54622
    • Private physician
  • Thessaloniki, Greece, 57010
    • "G. Papanikolaou" General University of Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nintedanib for CTD-associated PF-ILD patients in Greece; Connective Tissue Disease (CTD)-associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD)	Drug: Nintedanib; Nintedanib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Outcome Measure	Time Frame
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
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
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
Correlation between baseline FVC [% pred] and change in dyspnoea symptom score [points] from baseline at month 24	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 Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score [points] 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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Actual): May 13, 2026
• Study Completion (Actual): May 13, 2026

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; nintedanib
• Other Study ID Numbers: 1199-0501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No