AzTrials
AzTrials

AsthmaEXHALE 1ANCT04061291

Study to Explore the Relationship Between the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device Against Existing Measures of Lung Disease

An observational study of Asthma and COPD Exacerbation, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A cross-sectional, observational study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity and symptom control in patients with Asthma and COPD and volunteers with no history of lung disease. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Asthma, COPD Exacerbation
How many people
252 participants
Where
1 siteUnited Kingdom
Study dates
3 Feb 2018to 8 Aug 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Three populations of adult patients (all aged ≥18yrs) will be invited to participate: 1. Asthma patients (n=50, 25 mild, 25 severe) 2. COPD patients (n=50, 25 mild - moderate, 25 severe - very severe) 3. Comparator group (n=50) - Volunteers with no previous history of lung disease (our 'healthy' volunteers). These healthy volunteers will be recruited from the hospital staff. This will be facilitated by the hospital and research communications teams. Healthcare Professionals, who have assisted patients performing 'Inflammacheck™', alongside the standard respiratory tests of spirometry and FeNO, will be invited to participate in an experience outcome questionnaire at the end of the study.

Who may be able to join

  • • Male or Female, aged ≥16 years.
  • A confirmed, clinician made diagnosis of asthma for ≥ 6months supported by evidence of any of the following;
  • Airflow variability, with a variability in FEV1 or Peak Expiratory Flow (PEF) of >20% across clinic visits within the preceding 5 years, with concomitant evidence of airflow obstruction (FEV1/FVC ratio <70% on spirometry);
  • Airway reversibility with an improvement in FEV1 by ≥12% or 200 ml after inhalation of 400 μg of salbutamol (or equivalent bronchodilator) via a metered dose inhaler and spacer within the preceding 5 years;
  • Airway hyper-responsiveness demonstrated by Methacholine challenge testing with a provocative concentration of Methacholine required to cause a 20% reduction in FEV1 (PC20) of ≤ 16mg/ml or equivalent test.
  • Mild Asthma defined as GINA steps 1 to 3
Show all 13Show fewer
  • Severe asthma defined as GINA steps 4 or 5
  • OR a confirmed, clinician made diagnosis of COPD for ≥ 6months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC <0.7).
  • OR no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
  • Willing and able to give informed consent for participation in the study.
  • Healthcare Professionals Inclusion Criteria:
  • Assisted a minimum of 5 patients in performing the collection of EBC H2O2 levels using the 'Inflammacheck™' device during the study.
  • Willing and able to give informed consent for participation in the study.

Who cannot join

  • The participant may not enter the study if ANY of the following apply:
  • Existing co-morbidities that may prevent them from performing spirometry, FeNO or other study measurements (at the discretion of the clinical investigator).
  • Known lung, chest wall, neuromuscular, or cardiac disease or abnormality that would confound symptom scores and spirometry.
  • In the opinion of the clinical investigator, participant would not be able to perform any of the study procedures.
  • Unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Portsmouth Hospitals NHS Trust

    Portsmouth, Hampshire, PO6 3LY

Other trials in United Kingdom

About this study

Official title: A Cross-sectional Study to Explore the Relationship Between the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) Against Existing Measurements of Lung Disease and Inflammation in Patients With Asthma and COPD, and Healthy Volunteers.

A cross-sectional, observational study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity and symptom control in patients with Asthma and COPD and volunteers with no history of lung disease.

Read the detailed description

Current tools for assessing airway inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid lavage, are mostly invasive procedures that are not suitable for routine clinical practice or regular repeat sampling. Sample analysis requires a series of laboratory measurements and results can take over 24 hours to become available.

Induced sputum analysis is a semi-invasive means of assessing airway inflammation but is not always well tolerated by patients and again is not suitable for repeat sampling.

Non-invasive methods of measuring airway inflammation assess exhaled gases. Fractional exhaled Nitric Oxide (FeNO) measures eosinophilic airway inflammation. However, this test requires controlled exhalation for at least 6 seconds, making the test unsuitable for patients with impaired lung function, who are often not able to sustain this length of breath. Furthermore FeNO does not provide information about neutrophilic airway inflammation, a recognised component of steroid insensitive asthma and Chronic Obstructive Pulmonary Disease (COPD).

In contrast, 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.

To date, the measurement of EBC H2O2 has been used as a research tool only, due to the complex multiple procedural steps required to deliver a result from the collected exhaled breath. Exhalation Technology Ltd. have now developed a novel, handheld device (Inflammacheck™) which can produce an immediate measurement of EBC H2O2 levels at the patients side. By detecting EBC H2O2 levels immediately, Inflammacheck™ could tell clinicians and patients the current level of global airway inflammation in a simple, effort independent manner. This could be used by clinicians to diagnose asthma and COPD, to determine a patient's phenotype and to guide correct and personalised treatment. It could also measure increased levels of airway inflammation that may indicate an exacerbation.

The 'Inflammacheck™' device now requires a study in a clinical setting to determine whether it can differentiate asthma and COPD from healthy, whether it can distinguish mild from severe disease and whether it can detect an acute exacerbation of these chronic respiratory conditions. The acceptability and ease of use of the device also needs to be assessed for both patients and clinicians.

Medical subject headings
Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of exhaled breath condensate hydrogen peroxide (EBC H2O2),

    EBC H202 as measured by the by Inflammacheck™ sensor

    Measured: 1 day study visit

Secondary outcomes (5)

  1. Quality of life (asthma specific)

    measured by asthma quality of life questionnaire

    • Disease severity ( measured by GINA Stage for asthma, GOLD Stage for COPD)
    • Disease control (ACQ (asthma))

    Measured: 1 day study visit

  2. Quality of life (COPD specific)

    COPD assessment test

    • Rating of whether test is acceptable to participant
    • Participant's perception of device using the self perception questionnaire

    Measured: 1 day study visit

  3. Safety outcome

    incidence of adverse events reported during the study procedures

    Measured: 1 day study visit

  4. Disease Severity Asthma

    measured by Global Initiative for Asthma

    Measured: 1 day study visit

  5. Disease Severity COPD

    measured by Global Initiative for Chronic Obstructive Lung Disease

    Measured: 1 day study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2019
  2. Study start3 Feb 2018
  3. Primary completion8 Aug 2018
  4. Study completion8 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04061291
Sponsor's protocol ID
PHT/2017/120
Acronym
EXHALE 1A
Status last verified
May 2019
First submitted
3 May 2019
Last updated
19 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and COPD Exacerbation, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of exhaled breath condensate hydrogen peroxide (EBC H2O2), (time frame: 1 day study visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04061291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in