Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06383130

London Asthma Diagnostics Study

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO

    Time frame: 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 outcomes

  1. 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

    Time frame: 6 months

    To compare the sensitivity and specificity of pairwise permutations of testing

  2. To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: 6 months

    To assess the degree of agreement between each of the diagnostic tests

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

    Time frame: 6 months

    We will collect data on feasibility on each of the diagnostics (spirometry, FeNO, oscillometry)

Other outcomes

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

    Time frame: 6 months

    As an exploratory endpoint we will be optimising and assessing the diagnostic accuracy of a novel breath volatile organic compound test in asthma

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

    Time frame: 6 months

    As an exploratory endpoint we will be assessing the diagnostic accuracy of a novel nasal swab eosinophil protein biomarker for asthma

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

    Time frame: 6 months

    As an exploratory endpoint we will be assessing the diagnostic accuracy of handheld capnometry for asthma

Study contacts

Contact information is provided by the study sponsor or research team.

Salman Siddiqui, PhD

CONTACT

[email protected]

07989594095

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Asthma UK
  • General Practitioners Research Institute

Registry information

Official study title

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

Acronym: LADS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.