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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma
• Intervention / Treatment: Device: The Inflammacheck Device

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.

• Study Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• United Kingdom
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Three populations of older adolescent and adult patients (all aged ≥16yrs) will be invited to participate:

1. Asthma patients (n=30)
2. COPD patients (n=30)
3. Comparator group (n=30) - Volunteers with no previous history of lung disease.

Description

Inclusion Criteria:

• Subject has a clinician made diagnosis of asthma with symptoms for ≥ 3 months supported by objective evidence of airflow variability, reversibility or airway hyper-responsiveness
• Subject has a confirmed, clinician made diagnosis of COPD for ≥ 3 months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC <0.7) recorded at any time
• Subject has no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
• Subject is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

• Subject has existing co-morbidities that may prevent them from performing spirometry, FeNO or other study measurements (at the discretion of the clinical investigator).
• Subject has known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
• Subject has received treatment for an exacerbation of their respiratory disease within the last 2 weeks.
• In the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures.
• Subject is unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asthma Patients; 30 people who suffer from a confirmed diagnosis of asthma	Device: The Inflammacheck Device; A new hand-held, Non-invasive breathing test, that only requires tidal breathing.
Chronic Obstructive Pulmonary Disease Patients; 30 people who suffer from a confirmed diagnosis of COPD	Device: The Inflammacheck Device; A new hand-held, Non-invasive breathing test, that only requires tidal breathing.
Healthy Controls; 30 healthy volunteers who have no known diagnosis of Lung disease	Device: The Inflammacheck Device; A new hand-held, Non-invasive breathing test, that only requires tidal breathing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease severity as measured by Global Initiative for Asthma (GINA) Stage for asthma.	12 months
Disease severity as measured by Global Obstructive Lung Disease (GOLD) Stage for COPD.	12 months
Disease control as measured by the Asthma Control Questionnaire (ACQ) score for asthma patients.	12 months
Disease control as measured by the COPD Assessment Test (CAT) score for COPD patients.	12 months
Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) score in asthma patients	12 months
Lung function as recorded by the forced expiratory volume in 1 second (FEV1)	12 months
Eosinophilic Lung Inflammation as recorded by the exhaled Nitric Oxide level (FeNO).	12 months
Usability of inflammacheck device as measured by how frequently patients are unable to perform EBC collection by using the 'Inflammacheck' device.	6 months
Acceptability of the inflammacheck device as measured by a questionnaire of the participants and healthcare professionals experience of 'Inflammacheck'.	6 months

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Collaborators: Asthma UK
• Investigators: Principal Investigator: Prof Anoop J Chauhan, Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2016
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: PHT/2016/93