Investigation of Inflammacheck to Measure Exhaled Breath Condensate Hydrogen Peroxide in Respiratory Conditions (VICTORY)

A Single Visit, Cross-sectional, Observational Study of EBC H2O2 Levels and Other Exhaled Breath Condensate Parameters as Measured by Inflammacheck, in People With a Variety of Respiratory Conditions and Volunteers With no Known Lung Disease

People with lung conditions can suffer significantly with their symptoms and often require multiple trips to their GP or secondary care before a diagnosis is made. It can be difficult to diagnose lung disease and to differentiate between different lung conditions, so many people may be misdiagnosed or incorrectly not given a diagnosis. The tests currently used to diagnose lung diseases can be difficult or uncomfortable to do, especially if the person is experiencing lots of symptoms, and therefore can give poor or unreliable results.A new quick and easy to perform test is needed that can differentiate between various lung conditions and people with no lung disease, that can be performed in primary and secondary care with immediate results.

Study Overview

• Status: Completed
• Conditions: Respiratory Disease

Detailed Description

Lung disease is one of the largest contributors to morbidity and mortality in the UK, with 20% of the population diagnosed with, or receiving treatment for a respiratory condition.

Methods of diagnosis are still convoluted and can be difficult to perform, or very costly in patient and clinician time. Some diagnostic tests only look for a specific type of inflammation (e.g. Fractional exhaled Nitric Oxide) and so can overlook other causes. It can be hard to differentiate between different conditions, and as a result there are thousands of people in the UK who have undiagnosed or misdiagnosed respiratory disease.

Measurement of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) is performed during normal tidal breathing, and is well tolerated even in patients with severe airways obstruction and those unable to perform a consistent controlled exhalation. It is also not limited to inflammatory cell specific inflammation.

In studies using the previous version of the Inflammacheck™ device, significant differences have been demonstrated between levels of H2O2 in people with COPD, asthma, ILD and lung cancer compared to healthy controls. These studies have been instrumental in the continued improvement of the device, to ensure that the participant has the best experience, and simplify the procedure, so that the H2O2 result can be obtained with a single test in under 3 minutes.

Although the primary result of the Inflammacheck™ device is EBC H2O2, it is now also able to measure clinically important parameters including breath temperature, humidity, Carbon Dioxide waveforms, and intra-thoracic pressure changes. These parameters, in combination with the EBC H2O2 may be able to be used together to identify differences between people with various respiratory diseases and healthy volunteers. The device has also been improved based on the participant feedback, to ensure that it is user friendly and comfortable.

The investigators need to determine whether the parameters (H2O2, humidity, temperature, exhaled CO2 waveform and intra-thoracic pressure), as measured by 'Inflammacheck™' can either alone or in combination differentiate asthma, COPD, lung cancer, ILD, breathing pattern disorder, bronchiectasis and pneumonia from other each other and from healthy controls.

• Study Type: Observational
• Enrollment (Actual): 425

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: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with respiratory disease or healthy controls as defined in the inclusion and exclusion criteria

Description

Inclusion Criteria:

• Male or Female, aged ≥16 years
• A confirmed, clinician made diagnosis of the following (supported by standard accepted diagnostic criteria):
• Asthma with a ≤10 pack year smoking history (confirmed by spirometry and/or airway inflammation and function tests)
• COPD (confirmed by spirometry)
• Bronchiectasis (confirmed by CT scan)
• Interstitial Lung Disease (confirmed by CT scan and MDT/specialist consensus)
• has or is eventually proven to have a histological OR radiological and MDT confirmed diagnosis of primary lung cancer, and not yet started treatment for this
• current pneumonia (confirmed by chest imaging)
• Breathing Pattern Disorder, with no other significant respiratory co-morbidity (specialist confirmed)
• Healthy controls (defined as no current clinical diagnosis of, or be receiving treatment for, a lung or other significant medical disorder).
• Willing and able to give informed consent for participation in the study.
• In a stable state (at least 4 weeks after treatment of an exacerbation of their respiratory disease)

Exclusion Criteria:

• Existing co-morbidities that may prevent them from performing spirometry, for those with asthma, COPD, or healthy controls, with no spirometry in the previous 12 months (at the discretion of the clinical investigator).
• Unable to comprehend the study, provide informed consent, and unable to perform any of the study procedures.
• Requirement of supplemental oxygen (pneumonia participants only)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the levels of H2O2 in EBC in patients with a range of commonly occurring respiratory conditions	levels of H2O2 in Exhaled Breath Condensate	immediately after the procedure (breathing into device)
To measure humidity levels in EBC in patients with a range of commonly occurring respiratory conditions	level of humidity in breath in Exhaled Breath Condensate	immediately after the procedure (breathing into device)
To measure the breath temperature in EBC in patients with a range of commonly occurring respiratory conditions	temperature of breath in Exhaled Breath Condensate	immediately after the procedure (breathing into device)
To measure CO2 waveform in patients with a range of commonly occurring respiratory conditions	exhaled CO2 waveform	immediately after the procedure (breathing into device)
To measure intrathoracic pressure in patients with a range of commonly occurring respiratory conditions	intrathoracic pressure	immediately after the procedure (breathing into device)

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Actual): October 13, 2022
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

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: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: PHT/2019/77

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No