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Trial record 49 of 81427 for:    measured

Assessment of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) in Patients With Interstitial Lung Disease, Lung Cancer and Healthy Volunteers. (EXHALE 1B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04061356
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

Brief Summary:
A cross-sectional study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity in patients with ILD and Lung Cancer.

Condition or disease
Interstitial Lung Disease Lung Cancer

Detailed Description:

Inflammation and oxidative stress are processes that occur early in the disease process within both ILD and lung cancer. Current tools for assessing inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid lavage, are invasive procedures not suitable for regular repeat sampling. Sample analysis requires a series of laboratory measurements and results can take over 24 hours to become available.

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 patient's 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 ILD and even Lung Cancer.

The 'Inflammacheck™' device now requires a study in a clinical setting to determine whether it can detect ILD and Lung Cancer. The acceptability and ease of use of the device also needs to be assessed for both patients and clinicians.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) in Patients With Interstitial Lung Disease, Lung Cancer and Healthy Volunteers. The EXHALE 1B Study
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Primary Outcome Measures :
  1. Level of exhaled breath condensate hydrogen peroxide (EBC H2O2) [ Time Frame: 1 day study visit ]
    Respiratory outcome EBC H2O2 levels as measured by 'Inflammacheck™'

Secondary Outcome Measures :
  1. Experience outcome [ Time Frame: 1 day study visit ]
    rating of ease of use of test and participants perception of device as assessed by self completion questionnaire

  2. Disease Stage (lung cancer) [ Time Frame: 1 day study visit ]
    measured by Tumour, Node, Metastasis stage

  3. Disease stage (interstitial lung disease) [ Time Frame: 1 day study visit ]
    measured by the GAP index

  4. safety outcome [ Time Frame: 1 day study visit ]
    incidence of adverse events reported during the study procedures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
A total of 75 participants will be recruited, comprised of 50 participants with an established diagnosis that affects their breathing and 25 participants with no history of disease (healthy volunteers).

Inclusion Criteria:

  • Male or Female, aged ≥18 years.
  • A confirmed, clinician made diagnosis of Interstitial Lung Disease (ILD) supported by evidence of ILD on a CT chest scan recorded at any time.
  • OR a clinician suspected or confirmed Lung Cancer, with or without asthma and/or COPD
  • OR a healthy volunteer with 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.

Exclusion Criteria:

  • Existing co-morbidities that may prevent them from performing spirometry or other study measurements (at the discretion of the clinical investigator).
  • Known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
  • In the opinion of the clinical investigator, participant could be put at risk of harm by having 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04061356

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Contact: Anoop Chauhan 02392286000 ext 6263
Contact: Elaine Baddeley 02392286000 ext 6263

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United Kingdom
Portsmouth Hospitals NHS Trust Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact: Alice Mortlock    02392 286000 ext 6236   
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust

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Responsible Party: Portsmouth Hospitals NHS Trust Identifier: NCT04061356     History of Changes
Other Study ID Numbers: PHT/2017/121
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents