London Asthma Diagnostics Study

NCT ID: NCT06383130

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oscillometry with reversibility testing

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Nasal eosinophil peroxidase

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

Intervention Type DIAGNOSTIC_TEST

Handheld capnometry

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asthma UK

OTHER

Sponsor Role collaborator

General Practitioners Research Institute

NETWORK

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Salman Siddiqui, PhD

Role: CONTACT

07989594095

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eleanor Quek, MBBS

Role: primary

07411429994

Salman Siddiqui, PhD

Role: backup

Matthew Martin, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24SM8792

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Asthma Biomarker Study
NCT02392481 COMPLETED
Wessex Asthma Cohort of Difficult Asthma
NCT03996590 ACTIVE_NOT_RECRUITING