A Trial Evaluating Novel Technologies for the Diagnosis of Asthma The LUNG-TECH Trial
ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age17+
SponsorPortsmouth Hospitals NHS Trust
About this trial
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 treatment
The novel technology and devices will be entered into the pathway most suited to their stage of development, with this study design also allowing information collected for participants with a confirmed diagnosis of asthma in pathways 1 or 2 to be included in pathway 3. Participants will undergo the investigations currently used to diagnose asthma as well as using the novel devices being investigated in the relevant pathway.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial population
Participants will be recruited from outpatient and community respiratory clinics and local GP practices, with study activity taking place in both primary and secondary care.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
356 Participants
are grouped into 3 trial groupsGroup A: Pathway 1- Diagnostic case control study undertaken in a secondary care population
Group B: Pathway 2- Prospective diagnostic study undertaken in a primary care population
Group C: Pathway 3- A phenotypic characterisation study undertaken in participants with confirmed asthma
Trial outcomes
Primary outcomes
1
Pathway 1
The difference in each of the parameters (and combinations of these parameters), measured using the novel technology in patients with asthma, other respiratory conditions (COPD, BPD, bronchiectasis), and healthy volunteers As this is a pathway trial, it is not possible to define all of the parameters proactively as the novel devices included with the pathway will increase/change. This would be updated via amendments which will include devices and parameters
Time frame
3 months2
Pathway 2
Compare each device-specific parameter measured using the novel technology (and combinations of these parameters) between asthma, other respiratory conditions (COPD, BPD, bronchiectasis), and healthy volunteers Compare levels of device-specific parameters independently or in combination, that optimally discriminate between asthma, other respiratory conditions (COPD, BPD, bronchiectasis), and healthy volunteers. As this is a pathway trial, it is not possible to define all of the parameters proactively as the novel devices included with the pathway will increase/change. This would be updated via amendments which will include devices and parameters
Time frame
6 months3
Pathway 3
To assess the associations between each of the parameters (and combinations of these parameters) measured by the novel technology and the presence of: * T2 inflammation (defined by FeNO ≥40ppb and/or blood eosinophils ≥0.3x109/L) * SAD (IOS R5-R20 ≥0.1kPa/(L/s) and/or HRCT chest evidence of gas trapping * BPD defined by a BPAT score ≥4 or a specialist diagnosis As this is a pathway trial, it is not possible to define all of the parameters proactively as the novel devices included with the pathway will increase/change. This would be updated via amendments which will include devices and parameters
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov