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A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma

Study acronym: MODELS
StatusRecruiting
PhaseNot specified
Started2024-02-27
View on ClinicalTrials.gov ↗

Amendment history

2025-07-14
minor
Study Status, Oversight v4
Primary completion date2025-02→2027-05-27
2024-07-04
minor
Study Status, Study Design v3
Completion date2025-02→2027-05-27
Enrollment target750→2000
2024-07-01
minor
Study Status, Outcome Measures v2
Primary completion date2024-04-24→2025-02
Completion date2024-07-24→2025-02
Primary endpoints2 entries, revised
non-guideline physiologic criteria numbers
2024-04-02
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Conditions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02-26→confirmed 2024-02-27
Study sites0→1
Secondary endpoints2 entries, revised
Compare the clinical characteristics of patients stratified by the presence or absence of guideline and non-guideline physiologic criteria for asthma. Assess the sensitivityComparison of each guideline in the diagnosis of airway disease by comparing the diagnostic outcomes of each guideline with a "reference standard".
Primary endpoints2 entries, revised
AssessInternational theasthma presenceguidelines or absence of airway disease by the scores non-guideline physiologic criteria with those fulfilling (or not) the diagnostic criteria for asthma according to any of the selected guidelines. 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.
Study description+175 characters
[...] 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. OurThis study aims to evaluate the effectiveness of different diagn [...] a in adults is limited. To address these gaps in knowledge, wethe study will examine the data of patients attending the severe asth [...] Hospital in Portsmouth. With an "opt-out" consent proces [...]
2024-02-22
minor
Original filing
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.
Trial Details
NCT Number NCT06286085
Lead Sponsor Portsmouth Hospitals NHS Trust
Conditions Asthma
Enrollment 2,000 participants
Start Date 2024-02-27
Primary Completion 2027-05-27 (estimated)
Study Completion 2027-05-27 (estimated)
Updated on ClinicalTrials.gov 2026-09-17