Asthma Clinical Trial
— MODELSOfficial title:
A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma
NCT number | NCT06286085 |
Other study ID # | 337788 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 27, 2024 |
Est. completion date | July 24, 2024 |
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.
Status | Recruiting |
Enrollment | 750 |
Est. completion date | July 24, 2024 |
Est. primary completion date | April 24, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 COPD will be included. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Portsmouth Hospitals University NHS Trust | Portsmouth |
Lead Sponsor | Collaborator |
---|---|
Portsmouth Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | non-guideline physiologic criteria | 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 | 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. | during study analysis 4 weeks after recruitment | |
Secondary | 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". | during study analysis 4 weeks after recruitment |
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