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A Trial Evaluating Novel Technologies for the Diagnosis of Asthma The LUNG-TECH Trial

Recruitingn/aAges 17 Years - anyAllPortsmouth Hospitals NHS Trust
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In plain words

What the trial is, and whether it could suit you

This trial aims to evaluate novel diagnostic technologies for asthma in 3 different pathways providing the necessary evidence-base to allow adoption into clinical practice: * Pathway 1 evaluates whether the technology can distinguish between people with asthma and healthy volunteers, and other respiratory conditions in a well characterised secondary-care population and whether the parameters they measure correlate with the current standard diagnostic tests; * Pathway 2 assesses whether the technology can accurately diagnose asthma (either independently or alongside current diagnostic tests) in a primary care population of patients where there is a clinical suspicion of asthma; * Pathway 3 explores the ability of the technology to identify clinically important phenotypic characteristics which are difficult to measure in primary care and/or significantly impact on patient management and t

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📋 Eligibility rules (as published)
Inclusion Criteria: * • Diagnosis confirmed by a specialist supported by any of the following within the last 5-years: i) Evidence of variable and/or reversible airflow obstruction * FEV1/FVC ratio \<70% on spirometry with FEV1 ≥12% and 200 ml increase post-BD or * FEV1 variability ≥20% between clinic visits within 12-months or * R5-R20 ≥0.1kPa/(L/s) with ≥40% improvement post-BD or ii) Evidence of significant peak expiratory flow (PEF) variability * ≥ 20% PEF variability iii) Evidence of airway hyperresponsiveness (AHR) * Positive methacholine challenge test (PD20 ≤8mg/ml) or equivalent iv) Evidence of T2 airway inflammation * FeNO ≥40ppb * Poor disease control evidenced by an ACQ-6 score ≥1.5 * Not on a biologic therapy for severe asthma Exclusion Criteria: * • Known clinically significant chest wall, neuromuscular, cardiac or other co-morbidity or abnormality that would affect spirometry and/or other measures of lung function/inflammation (in the opinion of the investigator) * Respiratory tract infection/exacerbation of respiratory condition requiring systemic corticosteroids and/or antibiotic treatment within the last 2 weeks * Current smokers or Ex-smokers with \>20 PYH (other than COPD and asthma with significant smoking history group) * The participant is unable to provide informed consent or is unable to complete the study procedures Healthy Volunteers: * No current clinical diagnosis of (or treatment for) a respiratory disease and no treatment for a respiratory tract Infection within the last 6 months * Never smoker or ex-smoker with ≤10 pack-years smoking history, and stopped smoking at least 6-months prior to enrolment * Non-obstructive spirometry
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What it tests

  • Not listed
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Where

1 site
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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