Lung Diffusing Capacity for Nitric Oxide as a Marker of Fibrotic Changes in Idiopathic Interstitial Pneumonias (Dm&Vc)

November 2, 2015 updated by: Giovanni Barisione, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
The diagnosis of idiopathic interstitial pneumonia (IIP) is based on computed tomography (CT) imaging, whereas lung function studies are used for staging and follow up. Lung diffusing capacity for carbon monoxide (DLCO) is generally reduced but weakly correlated with the severity of CT-determined fibrotic process. A possible explanation of this finding is that DLCO is relatively insensitive to changes in alveolar membrane diffusive conductance (DMCO). Lung diffusion capacity for nitric oxide (DLNO) was strongly correlated with CT-determined amount of fibrosis/honeycombing in both usual and non-specific interstitial pneumonias. Moreover. Both DLNO and DMCO were below the lower limit of normality even in patients with small amount of fibrosis. Measurement of DLNO may provide a more reliable assessment of fibrotic changes than DLCO because it better reflects DMCO.

Study Overview

Status

Completed

Conditions

Detailed Description

Rationale: Lung diffusing capacity for carbon monoxide (DLCO) is decreased in both usual interstitial pneumonia-idiopathic pulmonary fibrosis (UIP-IPF) and nonspecific interstitial pneumonia (NSIP), but is weakly related to computed tomography (CT)-determined fibrotic changes.

Objectives: To determine whether measurement of lung diffusing capacity for nitric oxide (DLNO) better reflects fibrotic changes than DLCO.

Methods: DLNO and DLCO were measured simultaneously in 30 patients with UIP-IPF and 30 with NSIP. The amount of pulmonary fibrosis was estimated by volumetric analysis of visually bounded areas showing reticular opacities and honeycombing. Alveolar membrane conductance (DMCO) and pulmonary capillary volume (Vc) were calculated.

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The investigators used retrospectively collected data of 60 Caucasian patients with clinical and radiological features of Idiopathic Interstitial Pneumonias referred to Respiratory Pathophysiology Unit for a complete pulmonary function evaluation.

Description

Inclusion Criteria:

  • Chest computed tomography (CT) scan diagnosis of either usual interstitial pneumonia-idiopathic pulmonary fibrosis (UIP-IPF) or idiopathic nonspecific interstitial pneumonia (NSIP)

Exclusion Criteria:

  • Symptoms/signs or specific serum markers of an underlying autoimmune process
  • Previous environmental/occupational exposure to fibrogenic dusts
  • Use of fibrogenic medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of lung diffusing capacity for nitric oxide (DLNO) in a group of 60 patients with fibrosing idiopathic interstitial pneumonias (IIPs)
Time Frame: Within 1 month following idiopathic interstitial pneumonias diagnosis
Because DLNO is more sensitive to alveolar membrane diffusive conductance (DMCO) than standard lung diffusing capacity for carbon monoxide, DLNO changes may better reflect the extent of fibrotic process in IIPs
Within 1 month following idiopathic interstitial pneumonias diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (ESTIMATE)

November 4, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRCCS 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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