Mechanisms of Pulmonary Diffusion Limitation in Systemic Sclerosis

Completed

• Conditions: Diffusion Limitation of Pulmonary Gas Exchange in Systemic Sclerosis

• Registration Number: NCT03601520
• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Brief Summary

This study was designed to test the hypothesis that, irrespective of the degree of interstiaI lung disease and/or pulmonary arterial hypertension, the combined measurement of lung diffusing capacity for nitric oxide and carbon monoxide, might be useful to provide a mechanistic interpretation of changes of diffusion subcomponents in systemic sclerosis (SSc).

Detailed Description

In systemic sclerosis (SSc) the impairment of lung function is generally inferred from measurements of forced vital capacity (FVC) and standard lung diffusing capacity for carbon monoxide (DLCO). However, FVC measurement does not provide an accurate estimate of lung restriction and DLCO does not allow separate the alveolar membrane (DMCO) from erythrocyte (DeCO) diffusive conductance for CO. Previous studies have shown that DMCO and DeCO may change irrespective of overt intersitial lung disease (ILD) and/or pulmonary arterial hypertension (PAH). These changes may be consistent with a limitation of alveolar-capillary erythrocyte recruitment which impairs DM.This study was designed to test the hypothesis that, irrespective of the degree of ILD and/or PAH, combined DLNO-DLCO measurement might be useful to provide a mechanistic interpretation of DM and De changes in SSc.

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2017-10-31
• Study Completion: 2017-11-15
• Status Verified: 2018-07
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-17
• Last Update Submitted: 2018-07-25
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients fulfilling the 2013 American College of Rheumatology/European League Against Rheumatism criteria for a definite diagnosis of SSc with a total score ≥9

Exclusion Criteria

• unstable subjects and/or who have suffered from respiratory exacerbations in the previous 4-wk

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung diffusing capacity for nitric oxide	2 hours	Alveolar-capillary gas exchange