NCT04293588

Asthma: Phenotyping EXacerbations

Phenotyping Asthma Exacerbations: A Longitudinal Cohort Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main outcomes of this study are to establish a cohort of well-phenotyped asthma patients with a recent history of an exacerbation. We aim to describe exacerbation profiles (phenotypes) of the cohort in terms of inflammatory/biomarker profile and bacterial/viral infection status and to compare these with exacerbation events in the sister APEX cohort.

Detailed description

This is a single centre, observational, longitudinal cohort study. The study will consist of one group of approximately 200 patients with clinician diagnosed asthma, who have had at least one exacerbation in the past year before informed consent. They will be identified from secondary care, primary care and the Nottingham Respiratory Research Database (NRRD). After the Baseline visit, each subject will be followed for the duration of their participation in the study. Participants will be asked to contact the research team if they perceive that their asthma symptoms are worsening to the extent that they would usually seek help from a healthcare professional. They will then be invited to attend the Assessment Visit and potential Exacerbation Visit. Participants who complete this visit will then continue in the study, as we are interested in comparing subsequent events in the same individuals, to establish exacerbation stability and consistency. All participants, whether they have attended an Assessment visit or not, will be invited to attend for an Annual visit. The research team will also contact participants at 3 monthly intervals, with their permission, to discuss the study and provide updates.

Conditions

• Asthma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	spirometry, FOT, Induced sputum, bloods, nasal brushes, nasal lavage, skin prick, throat swab	At the point of baseline visit, exacerbation and annual visit, the above tests will be performed to allow comparison of a participants profile before and during an exacerbation

Timeline

• Start date: 2019-11-22
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-03-03
• Last updated: 2021-04-29

Locations

1 site across 1 country: United Kingdom