Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04095351

Connective Tissue Diseases and Lung Manifestations

Despite a number of prospective studies already initiated in the past years, the current epidemiology and course of interstitial lung disease (ILD) and pulmonary hypertension (PH) in patients with connective tissue disease (CTD) is still not well defined, particularly regarding its prevalence, incidence and the management of a broad spectrum of disease presentations.

Major challenges include the identification of patients with progressive disease, the appropriate time point of therapeutic intervention and the underlying driver of disease (inflammatory or pro-fibrotic stimulus or both?).

To address these issues in Western Austria, a progressive registry of patients with CTD exploring routine clinical and pathophysiological characteristics of ILD and PH will be conducted. This multidisciplinary, prospective and observational registry aims to collect comprehensive clinical data on incidence, prevalence and course of disease regarding all PH and ILD presentations in a real-world setting.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Connective Tissue Diseases Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Systemic Sclerosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck, Department of Internal Medicine II

Innsbruck, 6020, Austria

Location status: Recruiting

Location contact

Graziella Plank

CONTACT

About this study

Specifically, this registry will collect demographic data, disease-related clinical data, routine laboratory values (including antibody-profile and iron status), diagnostic procedures, significant comorbidities, therapeutic managements (e.g. thoracic ultrasound, HRCT), and disease outcomes over 10 years.

In addition, blood biobank samples for translational research will be collected in a subgroup of patients with systemic sclerosis over serial time points to study the systemic inflammatory and profibrotic phenotype of patients. In summary, this registry will monitor the disease course of pulmonary manifestations of patients with CTD and may be hypothesis-generating and provide new insights in underlying inflammatory/pro-fibrotic patterns.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The inclusion criteria are adult patients (≥18 years) diagnosed with CTD with signed informed consent.

Exclusion criteria

  • Exclusion criteria are patients with a serious co-morbidity interfering with the course of interstitial lung disease or pulmonary hypertension.

Treatment and study plan

Pulmonary Function Test

Diagnostic Test

Spirometry or plethysmography, measurement of diffusion capacity

Imaging

Diagnostic Test

Thoracic ultrasound, HRCT as scheduled within routine clinical examinations, echocardiography

Blood sampling

Biological

Standard laboratory test for CTDs as part of routine clinical examination

Primary outcomes

  1. Decline in forced vital capacity

    Time frame: 1 year

    Absolute decline from baseline in forced vital capacity percent predicted. Lung function tests are performed by a trained professional.

  2. Increase in the modified Rodnan Skin Score

    Time frame: 1 year

    Change in the modified Rodnan Skin Score from baseline of >5 Points assessed by a trained professional

  3. Decline in Diffusion capacity for carbon monoxide

    Time frame: 1 year

    Absolute decline from baseline in diffusion capacity for carbon monoxide in percent measured. Lung function tests are performed by a trained professional.

Study contacts

Contact information is provided by the study sponsor or research team.

Graziella Plank

CONTACT

[email protected]

+43 512-504-81884

Magdalena Aichner, MD

CONTACT

[email protected]

+43 512-504-83765

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)

Acronym: Colipris

Important dates

Study start
2019
Primary completion
2021
Study completion
2034
First posted
Sep 19, 2019
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.