Asthma Clinical Trial
— LADSOfficial title:
A Pragmatic Diagnostic Accuracy Study of a Triple Diagnostic Approach and Exploratory Biomarkers in Adult Asthma Diagnosis
NCT number | NCT06383130 |
Other study ID # | 24SM8792 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | July 2026 |
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
Status | Not yet recruiting |
Enrollment | 225 |
Est. completion date | July 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London | |
United Kingdom | Imperial College Healthcare NHS Trust | London | |
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Asthma UK, General Practitioners Research Institute |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To evaluate the diagnostic accuracy of the targeted reactive aldehyde species (RASP) panel in breath for asthma diagnosis | As an exploratory endpoint we will be optimising and assessing the diagnostic accuracy of a novel breath volatile organic compound test in asthma | 6 months | |
Other | To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX) | As an exploratory endpoint we will be assessing the diagnostic accuracy of a novel nasal swab eosinophil protein biomarker for asthma | 6 months | |
Other | To evaluate the diagnostic accuracy of tidal breath CO2 waveforms using the N-Tidal handheld capnometry device | As an exploratory endpoint we will be assessing the diagnostic accuracy of handheld capnometry for asthma | 6 months | |
Primary | To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO | 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. | 6 months | |
Secondary | 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 | To compare the sensitivity and specificity of pairwise permutations of testing | 6 months | |
Secondary | To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO) | To assess the degree of agreement between each of the diagnostic tests | 6 months | |
Secondary | To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests | We will collect data on feasibility on each of the diagnostics (spirometry, FeNO, oscillometry) | 6 months |
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