NCT03055923

EXhaled Hydrogen Peroxide As a Marker of Lung diseasE (EXHALE) Pilot Study.

A Cross-sectional, Feasibility Study to Explore the Use of a New Device (Inflammacheck™) in Measuring the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) in Patients With Asthma, COPD, and Healthy Volunteers. The EXHALE Pilot

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 149 (actual)
• Sponsor: Portsmouth Hospitals NHS Trust · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

This Pilot study evaluates the use of a new device called Inflammacheck and whether it can consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also assess whether exhaled breath condensate hydrogen peroxide levels as measured by Inflammacheck can differentiate people with asthma and COPD from healthy individuals.

Detailed description

Hydrogen Peroxide levels in Exhaled Breath Condensate (EBC) is a direct biomarker of oxidative stress from the airway epithelium. Levels have been shown to be raised in asthma and Chronic Obstructive Pulmonary Disease (COPD) both in stable and exacerbating states. Previously it has been difficult to measure this volatile compound away from a laboratory based setting. However a new device has been developed to measure Hydrogen peroxide levels in exhaled breath by the patients side. This Pilot study will test this new device in a clinical setting. It will assess whether the device can monitor levels consistently and reliably and whether it can distinguish disease from healthy individuals.

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	The Inflammacheck Device	A new hand-held, Non-invasive breathing test, that only requires tidal breathing.

Timeline

• Start date: 2016-11-14
• Primary completion: 2018-04-10
• Completion: 2018-04-10
• First posted: 2017-02-16
• Last updated: 2023-04-07

Locations

1 site across 1 country: United Kingdom