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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05503030
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Greece
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Diseases, Interstitial
Study Website: View Trial Website
Arms & Interventions

Arms

: Nintedanib for CTD-associated PF-ILD patients in Greece

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

Interventions

Drug: - Nintedanib

Nintedanib

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Private physician Dr. Goni, Athens, Greece

Status

Recruiting

Address

Private physician Dr. Goni

Athens, , 10676

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

Private physician Dr. Katsifis, Athens, Greece

Status

Recruiting

Address

Private physician Dr. Katsifis

Athens, , 11362

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

Athens, Greece

Status

Active, not recruiting

Address

General Hospital of Athens "G. Gennimatas"

Athens, , 11527

General Hospital of Athens "Ippokrateio", Athens, Greece

Status

Recruiting

Address

General Hospital of Athens "Ippokrateio"

Athens, , 11527

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

General Hospital of Athens "Laiko", Athens, Greece

Status

Recruiting

Address

General Hospital of Athens "Laiko"

Athens, , 11527

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

Private physician Dr. Karageorgas, Athens, Greece

Status

Recruiting

Address

Private physician Dr. Karageorgas

Athens, , 11634

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

University General Hospital ATTIKON, Athens, Greece

Status

Recruiting

Address

University General Hospital ATTIKON

Athens, , 12462

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

General Hospital KAT, Athens, Greece

Status

Recruiting

Address

General Hospital KAT

Athens, , 14561

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

University General Hospital of Heraklion, Heraklion, Greece

Status

Recruiting

Address

University General Hospital of Heraklion

Heraklion, , 71003

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

Private physician Dr. Georgiadis, Ioannina, Greece

Status

Recruiting

Address

Private physician Dr. Georgiadis

Ioannina, , 45332

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

University General Hospital of Ioannina, Ioannina, Greece

Status

Completed

Address

University General Hospital of Ioannina

Ioannina, , 45500

Private physician Prof. Sakkas, Larisa, Greece

Status

Recruiting

Address

Private physician Prof. Sakkas

Larisa, , 41222

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

University General Hospital of Larisa, Larisa, Greece

Status

Recruiting

Address

University General Hospital of Larisa

Larisa, , 41334

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

Private physician Dr. Iliadou, Nea Smirni, Athens, Greece

Status

Recruiting

Address

Private physician Dr. Iliadou

Nea Smirni, Athens, , 17121

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092

Private physician Dr Bounas, Patra, Greece

Status

Active, not recruiting

Address

Private physician Dr Bounas

Patra, , 26504

University General Hospital of Patras, Patra, Greece

Status

Active, not recruiting

Address

University General Hospital of Patras

Patra, , 26504

Private physician Dr. Triantafyllidou, Thessaloniki, Greece

Status

Active, not recruiting

Address

Private physician Dr. Triantafyllidou

Thessaloniki, , 54622

Thessaloniki, Greece

Status

Recruiting

Address

General Hospital of Thessaloniki "Hippokration"

Thessaloniki, , 54642

Site Contact

Boehringer Ingelheim

hellas@bitrialsupport.com

008000000092