Evaluating new technologies for diagnosing asthma

A Trial Evaluating Novel Technologies for the Diagnosis of Asthma

This study is testing new tools to see if they can help doctors better diagnose asthma in different healthcare settings.

Quick facts

• Study type: Observational
• Enrollment: 356 (estimated)
• Ages: 17 Years and up
• Sex: All
• Sponsor: Portsmouth Hospitals NHS Trust (other gov)
• Locations: 1 site (Portsmouth, Hampshire)
• Trial ID: NCT05819944 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with a confirmed asthma diagnosis and evidence of variable airflow obstruction or airway hyperresponsiveness.

Not a fit: Patients with significant comorbidities affecting lung function or those currently on biologic therapy for severe asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and efficient asthma diagnoses, improving patient management and outcomes.

How similar studies have performed: While the approach is innovative, similar studies evaluating diagnostic technologies for asthma have shown promise, suggesting potential for success.

Eligibility criteria

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 this trial is running

Portsmouth, Hampshire

• 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

Conditions: Asthma