Evaluating new technologies for diagnosing asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates novel diagnostic technologies for asthma through three distinct pathways. The first pathway assesses the technology's ability to differentiate asthma from other respiratory conditions and healthy individuals in a secondary care setting. The second pathway focuses on diagnosing asthma in primary care patients with suspected asthma, while the third pathway explores the technology's capacity to identify important phenotypic characteristics that impact patient management. The study aims to provide evidence for the adoption of these technologies into clinical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Portsmouth Hospitals University NHS Trust
  Portsmouth, Hampshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Thomas Dr Brown — Portsmouth Hospitals NHS Trust
• Study coordinator: Joe Mr Shoebridge
• Email: research.office@porthosp.nhs.uk
• Phone: 02392286236

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.