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

Nonspecific Interstitial Pneumonia Clinical Trial

— Dm&Vc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596841
• Other study ID #: IRCCS 2015
• Status: Completed
• Phase: N/A
• First received: October 29, 2015
• Last updated: November 2, 2015
• Start date: February 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Lung Diseases, Interstitial
• Nonspecific Interstitial Pneumonia
• Pneumonia
• Pulmonary Fibrosis
• Usual Interstitial Pneumonia

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (3)

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. — View Citation

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. — View Citation

Wémeau-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 1 month following idiopathic interstitial pneumonias diagnosis	No