Clinical trial NCT06383130: London Asthma Diagnostics Study
Official title: A Pragmatic Diagnostic Accuracy Study of a Triple Diagnostic Approach and Exploratory Biomarkers in Adult Asthma Diagnosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Asthma UK
name: General Practitioners Research Institute
First posted: 2024-04-25
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be eligible if being referred by their doctor for investigation for possible asthma, or for confirmation of asthma due to absence of objective diagnosis

Brief summary: The goal of this trial is to learn if the addition of oscillometry with reversibility testing increases diagnostic accuracy in adult asthma diagnosis, when added to current standard of care tests: spirometry with reversibility testing and Fractional Exhaled Nitric Oxide (FeNO). The main question it aims to answer is:

- Does oscillometry with reversibility testing increase diagnostic accuracy in detection of asthma in adults when added to spirometry with reversibility and FeNO?

Researchers will evaluate the diagnostic accuracy of this approach with the reference standard, which is a clinically adjudicated diagnosis of asthma by two respiratory clinicians based on history and investigation results.

Participants will

* Undergo oscillometry testing alongside their routine asthma investigations within their scheduled clinic visit
* Optionally participate in our sub-studies on new breath and nasal swab tests for asthma
* Optionally participate in our qualitative substudy on patients views and attitudes to asthma testing and oscillometry


Eligibility criteria: Inclusion Criteria:

* Patients referred by GP with either (a) possible incident asthma or (b) a diagnostic label of asthma without prior confirmatory objective diagnosis
* Age≥18 years
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
* Able to give informed consent

Exclusion Criteria:

* Age \<18 years
* A chest infection or exacerbation requiring antibiotics or steroids within 4 weeks of testing
* Contraindications to spirometry testing
* Established or coded diagnosis of COPD
* Pregnancy or lactating
* Other medical condition that in the opinion of the investigator would preclude compliance with the study protocoll
* Inability to understand English
* Involvement in Clinical Trial of an Investigational Medicinal Product

Primary outcomes:
measure: To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO
timeFrame: 6 months
Secondary outcomes:
measure: To conduct an analysis comparing the diagnostic accuracy of (i) oscillometry ± reversibility with spirometry ± reversibility, (ii) spirometry±reversibility with FeNO and (iii) oscillometry ±reversibility and FeNO
timeFrame: 6 months
measure: To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: 6 months
measure: To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests
timeFrame: 6 months
Other outcomes:
measure: To evaluate the diagnostic accuracy of the targeted reactive aldehyde species (RASP) panel in breath for asthma diagnosis
timeFrame: 6 months
measure: To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX)
timeFrame: 6 months
measure: To evaluate the diagnostic accuracy of tidal breath CO2 waveforms using the N-Tidal handheld capnometry device
timeFrame: 6 months
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
References: