Status:
COMPLETED
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
Lead Sponsor:
Portsmouth Hospitals NHS Trust
Conditions:
Asthma
COPD Exacerbation
Eligibility:
All Genders
16+ years
Brief 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 a...
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 no...
Eligibility Criteria
Inclusion
- • 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
- 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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 3 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 8 2018
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT04061291
Start Date
February 3 2018
End Date
August 8 2018
Last Update
August 19 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY