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CompletedNCT03055923EXHALE PilotUpdated Apr 7, 2023

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

An observational study in Asthma and Chronic Obstructive Pulmonary Disease, sponsored by Portsmouth Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by Portsmouth Hospitals NHS Trust · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
149
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma
  • Chronic Obstructive Pulmonary Disease
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 149 is close to the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
149 participants (actual)
Patient registry
No

Groups and cohorts

  • Asthma Patients

    30 people who suffer from a confirmed diagnosis of asthma

    Device: The Inflammacheck Device

  • Chronic Obstructive Pulmonary Disease Patients

    30 people who suffer from a confirmed diagnosis of COPD

    Device: The Inflammacheck Device

  • Healthy Controls

    30 healthy volunteers who have no known diagnosis of Lung disease

    Device: The Inflammacheck Device

Interventions

  • DeviceThe Inflammacheck Device

    A new hand-held, Non-invasive breathing test, that only requires tidal breathing.

06

What researchers measure

Primary outcomes

  1. Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device.

    Time frame: 12 months

Secondary outcomes

  1. Disease severity as measured by Global Initiative for Asthma (GINA) Stage for asthma.

    Time frame: 12 months

  2. Disease severity as measured by Global Obstructive Lung Disease (GOLD) Stage for COPD.

    Time frame: 12 months

  3. Disease control as measured by the Asthma Control Questionnaire (ACQ) score for asthma patients.

    Time frame: 12 months

  4. Disease control as measured by the COPD Assessment Test (CAT) score for COPD patients.

    Time frame: 12 months

  5. Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) score in asthma patients

    Time frame: 12 months

  6. Lung function as recorded by the forced expiratory volume in 1 second (FEV1)

    Time frame: 12 months

  7. Eosinophilic Lung Inflammation as recorded by the exhaled Nitric Oxide level (FeNO).

    Time frame: 12 months

  8. Usability of inflammacheck device as measured by how frequently patients are unable to perform EBC collection by using the 'Inflammacheck' device.

    Time frame: 6 months

  9. Acceptability of the inflammacheck device as measured by a questionnaire of the participants and healthcare professionals experience of 'Inflammacheck'.

    Time frame: 6 months

07

Study locations

1 site
  • Portsmouth Hospitals NHS Trust
    Portsmouth, PO6 3LY, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03055923
Lead sponsor
Portsmouth Hospitals NHS Trust
Collaborators
Asthma UK
Responsible party
Sponsor
First posted
Feb 16, 2017
Start date
Nov 14, 2016
Primary completion
Apr 10, 2018
Completion
Apr 10, 2018
Last update
Apr 7, 2023

Study contacts

Prof Anoop J Chauhan
principal investigator · Portsmouth Hospitals NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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