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

April 6, 2023 updated by: Portsmouth Hospitals NHS Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
425

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To measure the levels of H2O2 in EBC in patients with a range of commonly occurring respiratory conditions
Time Frame: immediately after the procedure (breathing into device)
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
Time Frame: immediately after the procedure (breathing into device)
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
Time Frame: immediately after the procedure (breathing into device)
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
Time Frame: immediately after the procedure (breathing into device)
exhaled CO2 waveform
immediately after the procedure (breathing into device)
To measure intrathoracic pressure in patients with a range of commonly occurring respiratory conditions
Time Frame: immediately after the procedure (breathing into device)
intrathoracic pressure
immediately after the procedure (breathing into device)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Portsmouth Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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