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CompletedNCT02596841Dm&VcUpdated Nov 4, 2015

Lung Diffusing Capacity for Nitric Oxide as a Marker of Fibrotic Changes in Idiopathic Interstitial Pneumonias

An observational study in Usual Interstitial Pneumonia and Nonspecific Interstitial Pneumonia, sponsored by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy. Completed. Per ClinicalTrials.gov, last updated 2015-11-04.

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

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
60
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Usual Interstitial Pneumonia
  • Nonspecific Interstitial Pneumonia

Keywords

  • Lung diffusing capacity
  • Idiopathic Interstitial Pneumonias
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 60 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy is the lead sponsor of 31 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Changes of lung diffusing capacity for nitric oxide (DLNO) in a group of 60 patients with fibrosing idiopathic interstitial pneumonias (IIPs)

    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

    Time frame: Within 1 month following idiopathic interstitial pneumonias diagnosis

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Guenard H, Varene N, Vaida P. Determination of lung capillary blood volume and membrane diffusing capacity in man by the measurements of NO and CO transfer. Respir Physiol. 1987 Oct;70(1):113-20. doi: 10.1016/s0034-5687(87)80036-1. PubMed 3659606 ↗
  • Borland CD, Higenbottam TW. A simultaneous single breath measurement of pulmonary diffusing capacity with nitric oxide and carbon monoxide. Eur Respir J. 1989 Jan;2(1):56-63. PubMed 2707403 ↗
  • Wemeau-Stervinou L, Perez T, Murphy C, Polge AS, Wallaert B. Lung capillary blood volume and membrane diffusion in idiopathic interstitial pneumonia. Respir Med. 2012 Apr;106(4):564-70. doi: 10.1016/j.rmed.2011.12.011. Epub 2012 Jan 4. PubMed 22221584 ↗
  • Barisione G, Brusasco C, Garlaschi A, Baroffio M, Brusasco V. Lung diffusing capacity for nitric oxide as a marker of fibrotic changes in idiopathic interstitial pneumonias. J Appl Physiol (1985). 2016 May 1;120(9):1029-38. doi: 10.1152/japplphysiol.00964.2015. Epub 2016 Feb 18. PubMed 26893034 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02596841
Lead sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Responsible party
Giovanni Barisione (MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy) — Principal investigator
First posted
Nov 4, 2015
Start date
Feb 2013
Primary completion
May 2015
Completion
Aug 2015
Last update
Nov 4, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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