Clinical trial NCT03055923: EXhaled Hydrogen Peroxide As a Marker of Lung diseasE (EXHALE) Pilot Study.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Asthma UK
First posted: 2017-02-16
Enrollment: 149
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device.
timeFrame: 12 months
Secondary outcomes:
measure: Disease severity as measured by Global Initiative for Asthma (GINA) Stage for asthma.
timeFrame: 12 months
measure: Disease severity as measured by Global Obstructive Lung Disease (GOLD) Stage for COPD.
timeFrame: 12 months
measure: Disease control as measured by the Asthma Control Questionnaire (ACQ) score for asthma patients.
timeFrame: 12 months
measure: Disease control as measured by the COPD Assessment Test (CAT) score for COPD patients.
timeFrame: 12 months
measure: Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) score in asthma patients
timeFrame: 12 months
measure: Lung function as recorded by the forced expiratory volume in 1 second (FEV1)
timeFrame: 12 months
measure: Eosinophilic Lung Inflammation as recorded by the exhaled Nitric Oxide level (FeNO).
timeFrame: 12 months
measure: Usability of inflammacheck device as measured by how frequently patients are unable to perform EBC collection by using the 'Inflammacheck' device.
timeFrame: 6 months
measure: Acceptability of the inflammacheck device as measured by a questionnaire of the participants and healthcare professionals experience of 'Inflammacheck'.
timeFrame: 6 months
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Prof Anoop J Chauhan
role: PRINCIPAL_INVESTIGATOR
References: