London Asthma Diagnostics Study (LADS)

April 19, 2024 updated by: Imperial College London

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1PG
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom, W21NY
        • Imperial College Healthcare NHS Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salman Siddiqui, PhD
      • Nottingham, United Kingdom, NG7 2UH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: 6 months
To assess the degree of agreement between each of the diagnostic tests
6 months
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)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Asthma UK
General Practitioners Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24SM8792

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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