London Asthma Diagnostics Study
- Conditions
- Asthma
- Registration Number
- NCT06383130
- Lead Sponsor
- Imperial College London
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 225
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO 6 months To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO for adult asthma diagnosis compared to the diagnostic reference standard.
- Secondary Outcome Measures
Name Time Method 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 6 months To compare the sensitivity and specificity of pairwise permutations of testing
To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO) 6 months To assess the degree of agreement between each of the diagnostic tests
To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests 6 months We will collect data on feasibility on each of the diagnostics (spirometry, FeNO, oscillometry)
Trial Locations
- Locations (2)
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom