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RecruitingNCT06286085MODELSUpdated Sep 17, 2026

A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma

An observational study in Asthma, sponsored by Portsmouth Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Portsmouth Hospitals NHS Trust · Observational

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Asthma is a widespread condition that affects millions of people worldwide. It is characterized by symptoms such as difficulty breathing, coughing, and wheezing. Diagnosing asthma involves identifying certain indicators like airflow obstruction, airway sensitivity, and inflammation. However, different international guidelines, including those from organizations such as NICE (National Institute for Health and Care Excellence), GINA (Global Initiative for Asthma), and BTS (British Thoracic Society)/SIGN (Scottish Intercollegiate Guidelines Network), have varying criteria for diagnosis. This can lead to inconsistencies in identifying patients with asthma.

This study aims to evaluate the effectiveness of different diagnostic approaches, including impulse oscillometry (IOS), in diagnosing asthma. IOS is a simple and non-invasive test that measures lung function. It has the potential to enhance the accuracy and ease of asthma diagnosis. Despite its promise, current research on the role of IOS in diagnosing asthma in adults is limited.

To address these gaps in knowledge, the study will examine the data of patients attending the severe asthma service at Queen Alexandra Hospital in Portsmouth. With an "opt-out" consent process, routine outpatient lung function data will be analysed, paying special attention to the usefulness of IOS compared to other lung function indices in diagnosing asthma.

By conducting this study, the aim is to contribute valuable insights to the field of asthma diagnosis. The study findings may help refine the methodology of diagnosing asthma and potentially expand the diagnostic toolkit to include IOS. This could improve the precision and ease of managing asthma, leading to better outcomes for patients.

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Conditions studied

  • Asthma

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Keywords

  • lung function
  • impulse oscillometry
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In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 158 across 1,250 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 will be included.

Exclusion criteria

Exclusion Criteria:

  • The participant may not enter the study if either of the following apply:

    • Unable to comprehend the study and provide , e.g., insufficient command of English in the absence of someone who can adequately interpret.
    • Patients with other primary respiratory conditions, such as ILD.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Interventions

  • OtherLung function tests

    Pulmonary function tests

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: during study analysis 4 weeks after recruitment

  2. 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.

    Time frame: during study analysis 4 weeks after recruitment

Secondary outcomes

  1. non-guideline physiologic criteria for asthma.

    Compare the clinical characteristics of patients stratified by the presence or absence of guideline and non-guideline physiologic criteria for asthma.

    Time frame: during study analysis 4 weeks after recruitment

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

    Assess the sensitivity of each guideline in the diagnosis of airway disease by comparing the diagnostic outcomes of each guideline with a "reference standard".

    Time frame: during study analysis 4 weeks after recruitment

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No — No data will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06286085
Lead sponsor
Portsmouth Hospitals NHS Trust
Responsible party
Sponsor
First posted
Feb 29, 2024
Start date
Feb 27, 2024
Primary completion
May 27, 2027 (estimated)
Completion
May 27, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

celia Selvin-Premkumar
Contact
celia.selvin-premkumar@porthosp.nhs.uk
02392 286000 ext. 1367
Anoop Chauhan
principal investigator · Portsmouth University Hospital Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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