Health TrialsbyHealthPanel

Connective Tissue Diseases and Lung Manifestations

ConditionsConnective Tissue DiseasesInterstitial Lung DiseaseSystemic Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMedical University Innsbruck

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Real-life cohort of CTD patients

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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/Vaccine

    Standard laboratory test for CTDs as part of routine clinical examination

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Decline in forced vital capacity

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

Time frame
1 year
2

Increase in the modified Rodnan Skin Score

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

Time frame
1 year
3

Decline in Diffusion capacity for carbon monoxide

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

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University Innsbruck

Lead sponsor

Boehringer Ingelheim

Collaborator

Source ClinicalTrials.gov
Apply now