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

Last updated: January 9, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Connective Tissue Diseases

Musculoskeletal Diseases

Treatment

Nintedanib

Clinical Study ID

NCT05503030
1199-0501
  • Ages > 18
  • All Genders

Study 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

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 ProductCharacteristics (SmPC) and clinical judgment. Therapy with nintedanib must have beenstarted for clinical reasons independently from the intended patient enrolment intothe study at a maximum of 15 days before enrolment into the trial.

Exclusion

Exclusion Criteria:

  • Patients currently receiving treatment with any investigationaldrug/device/intervention or who have received any investigational product within 1month or 5 half-lives of the investigational agent (whichever is longer) before thecommencement of therapy with nintedanib

  • Patients at baseline with a known condition or reason that will result in withdrawalfrom the study before the 24-month time point

  • Pregnancy or lactation

Study Design

Total Participants: 87
Treatment Group(s): 1
Primary Treatment: Nintedanib
Phase:
Study Start date:
December 21, 2022
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • "ATTIKON" University General Hospital

    Athens, 12462
    Greece

    Site Not Available

  • "G. Gennimatas" General Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • "Ippokration" General Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • "KAT" General Hospital

    Athens, 14561
    Greece

    Site Not Available

  • "Laiko" General Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • General Hospital KAT

    Athens, 14561
    Greece

    Active - Recruiting

  • General Hospital of Athens "G. Gennimatas"

    Athens, 11527
    Greece

    Site Not Available

  • General Hospital of Athens "Ippokrateio"

    Athens, 11527
    Greece

    Active - Recruiting

  • General Hospital of Athens "Laiko"

    Athens, 11527
    Greece

    Active - Recruiting

  • Private physician

    Athens, 11362
    Greece

    Site Not Available

  • Private physician Dr. Goni

    Athens, 10676
    Greece

    Active - Recruiting

  • Private physician Dr. Karageorgas

    Athens, 11634
    Greece

    Active - Recruiting

  • Private physician Dr. Katsifis

    Athens, 11362
    Greece

    Active - Recruiting

  • University General Hospital ATTIKON

    Athens, 12462
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion

    Heraklion, 71003
    Greece

    Site Not Available

  • Private physician

    Ioannina, 45332
    Greece

    Site Not Available

  • Private physician Dr. Georgiadis

    Ioannina, 45332
    Greece

    Active - Recruiting

  • University General Hospital of Ioannina

    Ioannina, 45500
    Greece

    Site Not Available

  • Private physician

    Larisa, 41222
    Greece

    Site Not Available

  • Private physician Prof. Sakkas

    Larisa, 41222
    Greece

    Active - Recruiting

  • University General Hospital of Larisa

    Larisa, 41334
    Greece

    Site Not Available

  • Private physician

    Nea Smirni, Athens, 17121
    Greece

    Site Not Available

  • Private physician Dr. Iliadou

    Nea Smirni, Athens, 17121
    Greece

    Active - Recruiting

  • Private physician

    Patra, 26504
    Greece

    Site Not Available

  • Private physician Dr Bounas

    Patra, 26504
    Greece

    Active - Recruiting

  • University General Hospital of Patra

    Patra, 26504
    Greece

    Site Not Available

  • University General Hospital of Patras

    Patra, 26504
    Greece

    Site Not Available

  • University General Hospital of Patras

    Patras, 26504
    Greece

    Site Not Available

  • "G. Papanikolaou" General University of Thessaloniki

    Thessaloniki, 57010
    Greece

    Site Not Available

  • "Hippokration" General Hospital of Thessaloniki

    Thessaloniki, 54642
    Greece

    Site Not Available

  • Clinic "Agios Loukas"

    Thessaloniki, 57010
    Greece

    Site Not Available

  • General Hospital of Thessaloniki "Hippokration"

    Thessaloniki, 54642
    Greece

    Active - Recruiting

  • Private physician

    Thessaloniki, 54622
    Greece

    Site Not Available

  • Private physician Dr. Theodoridou

    Thessaloniki, 54623
    Greece

    Site Not Available

  • Private physician Dr. Triantafyllidou

    Thessaloniki, 54622
    Greece

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.