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Completed

NCT Number: NCT03055923

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Inflammacheck Device

Device

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

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

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Collaborators

  • Asthma UK

Registry information

Official study 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

Acronym: EXHALE Pilot

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2017
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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