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

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ClinicalTrials.gov Identifier: NCT03055923
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : September 20, 2017
Sponsor:
Collaborator:
Asthma UK
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
Asthma Chronic Obstructive Pulmonary Disease Device: The Inflammacheck Device

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official 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
Study Start Date : November 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Asthma Patients
30 people who suffer from a confirmed diagnosis of asthma
Device: The Inflammacheck Device
A new hand-held, Non-invasive breathing test, that only requires tidal breathing.

Chronic Obstructive Pulmonary Disease Patients
30 people who suffer from a confirmed diagnosis of COPD
Device: The Inflammacheck Device
A new hand-held, Non-invasive breathing test, that only requires tidal breathing.

Healthy Controls
30 healthy volunteers who have no known diagnosis of Lung disease
Device: The Inflammacheck Device
A new hand-held, Non-invasive breathing test, that only requires tidal breathing.




Primary Outcome Measures :
  1. Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Three populations of older adolescent and adult patients (all aged ≥16yrs) will be invited to participate:

  1. Asthma patients (n=30)
  2. COPD patients (n=30)
  3. Comparator group (n=30) - Volunteers with no previous history of lung disease.
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03055923


Contacts
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Contact: Anoop J Chauhan, PhD anoop.chauhan@porthosp.nhs.uk
Contact: Daniel M Neville, MBBS BSc daniel.neville@porthosp.nhs.uk

Locations
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United Kingdom
Portsmouth Hospitals NHS Trust Recruiting
Portsmouth, United Kingdom, PO6 3LY
Contact: Anoop J Chauhan, PhD       anoop.chauhan@porthosp.nhs.uk   
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
Asthma UK
Investigators
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Principal Investigator: Prof Anoop J Chauhan Portsmouth Hospitals NHS Trust

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Responsible Party: Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03055923     History of Changes
Other Study ID Numbers: PHT/2016/93
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents