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

NCT05503030 | Active Not Recruiting

• 1 other identifier: 1199-0501
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 20

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.

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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 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 FVC [% pred] at month 24

  At baseline and at month 24

Study Arms (1)

Nintedanib for CTD-associated PF-ILD patients in Greece

Connective Tissue Disease (CTD)-associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Drug: Nintedanib

Interventions

Nintedanib DRUG

Nintedanib

Nintedanib for CTD-associated PF-ILD patients in Greece

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (20)

Private physician

Athens, 10676, Greece

Location

Private physician

Athens, 11362, Greece

Location

"G. Gennimatas" General Hospital of Athens

Athens, 11527, Greece

Location

"Ippokration" General Hospital of Athens

Athens, 11527, Greece

Location

"Laiko" General Hospital of Athens

Athens, 11527, Greece

Location

Private physician

Athens, 11634, Greece

Location

"ATTIKON" University General Hospital

Athens, 12462, Greece

Location

"KAT" General Hospital

Athens, 14561, Greece

Location

University General Hospital of Heraklion

Heraklion, 71003, Greece

Location

University General Hospital of Heraklion

Heraklion, 71110, Greece

Location

Private physician

Ioannina, 45332, Greece

Location

University General Hospital of Ioannina

Ioannina, 45500, Greece

Location

Private physician

Larissa, 41222, Greece

Location

University General Hospital of Larisa

Larissa, 41334, Greece

Location

Private physician

Nea Smirni, Athens, 17121, Greece

Location

Private physician

Pátrai, 26504, Greece

Location

University General Hospital of Patra

Pátrai, 26504, Greece

Location

Private physician

Thessaloniki, 54622, Greece

Location

"Hippokration" General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

"G. Papanikolaou" General University of Thessaloniki

Thessaloniki, 57010, Greece

Location

Related Links

• Related Info

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 16, 2022
• Study Start: December 21, 2022
• Primary Completion (Estimated): May 11, 2026
• Study Completion (Estimated): May 11, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

GR (20)