London Asthma Diagnostics Study

NCT06383130 | Not Yet Recruiting

• 1 other identifier: 24SM8792
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 3

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO)

  6 months

• To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests

  6 months

Other Outcomes (3)

• To evaluate the diagnostic accuracy of the targeted reactive aldehyde species (RASP) panel in breath for asthma diagnosis

  6 months

• To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX)

  6 months

• To evaluate the diagnostic accuracy of tidal breath CO2 waveforms using the N-Tidal handheld capnometry device

  6 months

Interventions

Oscillometry with reversibility testing DIAGNOSTIC_TEST

Oscillometry is a test that uses sound waves to measure the mechanical properties in the lungs during tidal breathing

Breath volatile testing DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

We will be evaluating the sensitivity and specificity of a novel nasal swab test for eosinophil peroxidase

Handheld capnometry DIAGNOSTIC_TEST

We will be evaluating handheld capnometry (carbon dioxide breath testing) to diagnose adult asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Asthma UK: collaborator
• General Practitioners Research Institute: collaborator

Study Sites (3)

Imperial College Healthcare NHS Trust

London, W2 1PG, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W21NY, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

RNA

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Salman Siddiqui, PhD

CONTACT

07989594095; s.siddiqui@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 25, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)