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

NCT ID: NCT05503030

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-21

Study Completion Date

2025-09-12

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Diseases, Interstitial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nintedanib for CTD-associated PF-ILD patients in Greece

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

Nintedanib

Intervention Type DRUG

Nintedanib

Interventions

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Nintedanib

Nintedanib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Private physician

Athens, , Greece

Site Status

Private physician

Athens, , Greece

Site Status

"G. Gennimatas" General Hospital of Athens

Athens, , Greece

Site Status

"Ippokration" General Hospital of Athens

Athens, , Greece

Site Status

"Laiko" General Hospital of Athens

Athens, , Greece

Site Status

Private physician

Athens, , Greece

Site Status

"ATTIKON" University General Hospital

Athens, , Greece

Site Status

"KAT" General Hospital

Athens, , Greece

Site Status

University General Hospital of Heraklion

Heraklion, , Greece

Site Status

University General Hospital of Heraklion

Heraklion, , Greece

Site Status

Private physician

Ioannina, , Greece

Site Status

University General Hospital of Ioannina

Ioannina, , Greece

Site Status

Private physician

Larissa, , Greece

Site Status

University General Hospital of Larisa

Larissa, , Greece

Site Status

Private physician

Nea Smirni, Athens, , Greece

Site Status

Private physician

Pátrai, , Greece

Site Status

University General Hospital of Patra

Pátrai, , Greece

Site Status

Private physician

Thessaloniki, , Greece

Site Status

"Hippokration" General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status

"G. Papanikolaou" General University of Thessaloniki

Thessaloniki, , Greece

Site Status

Countries

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Greece

Related Links

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Other Identifiers

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1199-0501

Identifier Type: -

Identifier Source: org_study_id

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