A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma

NCT06286085 | Recruiting

• 1 other identifier: 337788
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the concordance of international asthma guidelines in the diagnosis of asthma and explore the presence of airways disease using additional non-guideline physiologic criteria, such as IOS (impulse osciollometry), not included in the guidelines, but available in the Portsmouth lung function service.

Conditions

Asthma

Keywords

lung function; impulse oscillometry

Outcome Measures

Primary Outcomes (2)

• International asthma guidelines scores

  To assess the levels of concordance among international asthma guidelines for the diagnosis of asthma in patients referred to a secondary/tertiary care asthma service.

  during study analysis 4 weeks after recruitment

• non-guideline physiologic criteria numbers

  Assess the presence or absence of airway disease by the non-guideline physiologic criteria with those fulfilling (or not) the diagnostic criteria for asthma according to any of the selected guidelines.

  during study analysis 4 weeks after recruitment

Secondary Outcomes (2)

• non-guideline physiologic criteria for asthma.

  during study analysis 4 weeks after recruitment

• Comparison of the diagnostic outcomes of each guideline with a "reference standard".

  during study analysis 4 weeks after recruitment

Interventions

Lung function tests OTHER

Pulmonary function tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients referred for specialist review from primary care and needing specialist review after emergency admission. This research will utilise historical and contemporary data from pulmonary function tests performed during the asthma workup at the Queen Alexandra Hospital, Portsmouth. The tests will include Fractional Exhaled Nitric Oxide (FeNO), Skin prick tests, Impulse Oscillometry, Spirometry, Gas transfer, lung volumes and Bronchodilator reversibility.

You may qualify if:

• The patient will meet all the following criteria to be considered eligible for the study:
• Aged 18 years or over.
• All patients who have attended full asthma workups from November 2021 till date
• Willing and able to consent to use their data in this study (opt-out form or e-consent).
• Patients referred to the Portsmouth asthma service for diagnosis and further management of presumed asthma. Comorbidities are common in asthma, thus patients with co-existing conditions such as obesity, bronchiectasis or COPD will be included.

You may not qualify if:

• The participant may not enter the study if either of the following apply:
• Unable to comprehend the study and provide informed consent, e.g., insufficient command of English in the absence of someone who can adequately interpret.
• Patients with other primary respiratory conditions, such as ILD.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals University NHS Trust

Portsmouth, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

• Anoop Chauhan

  Portsmouth University Hospital Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

celia Selvin-Premkumar

CONTACT

02392 286000; celia.selvin-premkumar@porthosp.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): May 27, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)