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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date April 2024
Source Imperial College London
Contact Salman Siddiqui, PhD
Phone 07989594095
Email s.siddiqui@imperial.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Oscillometry with reversibility testing
Oscillometry is a test that uses sound waves to measure the mechanical properties in the lungs during tidal breathing
Breath volatile testing
We will be optimising and evaluating the sensitivity and specificity of a novel breath volatile organic compound test of a combination of reactive aldehydes using a gas chromatography-ion mobility spectrometry device
Nasal eosinophil peroxidase
We will be evaluating the sensitivity and specificity of a novel nasal swab test for eosinophil peroxidase
Handheld capnometry
We will be evaluating handheld capnometry (carbon dioxide breath testing) to diagnose adult asthma

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Imperial College London Asthma UK, General Practitioners Research Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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