NCT03601520

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

3.7 years

First QC Date

July 17, 2018

Last Update Submit

July 25, 2018

Conditions

Diffusion Limitation of Pulmonary Gas Exchange in Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Lung diffusing capacity for nitric oxide

    Alveolar-capillary gas exchange

    2 hours

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

SSc patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Barisione G, Bacigalupo A, Brusasco C, Scanarotti C, Penco S, Bassi AM, Lamparelli T, Garlaschi A, Pellegrino R, Brusasco V. Mechanisms for reduced pulmonary diffusing capacity in haematopoietic stem-cell transplantation recipients. Respir Physiol Neurobiol. 2014 Apr 1;194:54-61. doi: 10.1016/j.resp.2014.01.018. Epub 2014 Feb 1.

    PMID: 24495442BACKGROUND

  • 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.

    PMID: 26893034BACKGROUND

  • Barisione G, Garlaschi A, Occhipinti M, Baroffio M, Pistolesi M, Brusasco V. Value of lung diffusing capacity for nitric oxide in systemic sclerosis. Physiol Rep. 2019 Aug;7(13):e14149. doi: 10.14814/phy2.14149.

    PMID: 31264386DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Pulmonary Function Lab Director

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

March 1, 2014

Primary Completion

October 31, 2017

Study Completion

November 15, 2017

Last Updated

July 27, 2018

Record last verified: 2018-07