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

NCT05819944 | Recruiting

• 1 other identifier: PHU/2022/36
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• 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

  3 months

• 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

  6 months

• 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

  6 months

Study Arms (3)

Pathway 1- Diagnostic case control study undertaken in a secondary care population

evaluates whether the technology can distinguish between people with asthma and healthy volunteers, and other respiratory conditions in a well characterised secondary care population;

Pathway 2- Prospective diagnostic study undertaken in a primary care population

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- A phenotypic characterisation study undertaken in participants with confirmed asthma

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;

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals University NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Thomas Dr Brown

  Portsmouth Hospitals University NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe Mr Shoebridge

CONTACT

02392286236; research.office@porthosp.nhs.uk

Laura Marshall

CONTACT

02392 286000; laura.marshall2@porthosp.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: April 19, 2023
• Study Start: January 9, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)