NCT02596841

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

2.2 years

First QC Date

October 29, 2015

Last Update Submit

November 2, 2015

Conditions

Keywords

Lung diffusing capacityIdiopathic Interstitial Pneumonias

Outcome Measures

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

    Within 1 month following idiopathic interstitial pneumonias diagnosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 3659606BACKGROUND
  • 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.

    PMID: 2707403BACKGROUND
  • 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.

    PMID: 22221584BACKGROUND
  • 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.

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisIdiopathic Interstitial Pneumonias

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 4, 2015

Study Start

February 1, 2013

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

November 4, 2015

Record last verified: 2015-11