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| Name | Class |
|---|---|
| Asthma UK | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma Patients | 30 people who suffer from a confirmed diagnosis of asthma |
| |
| Chronic Obstructive Pulmonary Disease Patients | 30 people who suffer from a confirmed diagnosis of COPD |
| |
| Healthy Controls | 30 healthy volunteers who have no known diagnosis of Lung disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Inflammacheck Device | Device | A new hand-held, Non-invasive breathing test, that only requires tidal breathing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease severity as measured by Global Initiative for Asthma (GINA) Stage for asthma. | 12 months | |
| Disease severity as measured by Global Obstructive Lung Disease (GOLD) Stage for COPD. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Three populations of older adolescent and adult patients (all aged ≥16yrs) will be invited to participate:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Anoop J Chauhan | Portsmouth Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospitals NHS Trust | Portsmouth | PO6 3LY | United Kingdom |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Disease control as measured by the Asthma Control Questionnaire (ACQ) score for asthma patients. | 12 months |
| Disease control as measured by the COPD Assessment Test (CAT) score for COPD patients. | 12 months |
| Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) score in asthma patients | 12 months |
| Lung function as recorded by the forced expiratory volume in 1 second (FEV1) | 12 months |
| Eosinophilic Lung Inflammation as recorded by the exhaled Nitric Oxide level (FeNO). | 12 months |
| Usability of inflammacheck device as measured by how frequently patients are unable to perform EBC collection by using the 'Inflammacheck' device. | 6 months |
| Acceptability of the inflammacheck device as measured by a questionnaire of the participants and healthcare professionals experience of 'Inflammacheck'. | 6 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |