London Asthma Diagnostics Study

Asthma Clinical Trial

— LADS  

Official title:

A Pragmatic Diagnostic Accuracy Study of a Triple Diagnostic Approach and Exploratory Biomarkers in Adult Asthma Diagnosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383130
• Other study ID #: 24SM8792
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Asthma

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