A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma
ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPortsmouth Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lung function tests
Other interventionPulmonary function tests
Treatment groups
No treatment groups listed
Trial outcomes
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 recruitment2
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 recruitmentSecondary 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 recruitment2
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 recruitmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov