Asthma: Phenotyping Exacerbations 2
- Conditions
- ASTHMA
- Registration Number
- NCT04293445
- Lead Sponsor
- University of Nottingham
- Brief 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
A single centre, observational, longitudinal cohort study. The study will consist of one group of approximately 100 patients with clinician diagnosed asthma, who have had at least one exacerbation in the past 5 years 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of study participants with an eosinophilic and non eosinophhilic phenotype 3 years Percentage of study participants with an eosinophilic and non eosinophhilic phenotype
- Secondary Outcome Measures
Name Time Method Blood profile 3 years Measure FBC CRP IgE at baseline. During an exacerbation and Annual visit FBC CRP will be measured. Additional bloods will be taken at each visit for future research
Skin Prick testing 3 years. Skin prick tests will be performed on all patients at baseline to assess if they are sensitive to common allergens and would be suggestive of atopy
Nasal brushes 3 years Nasal brush samples will be obtained to identify viral genetics at baseline, exacerbation and annual visits
Asthma control questionnaire 3 years ACQ score at baseline and then at exacerbation and annual visits. 0 is total control and 6 is severely uncontrolled
Medication Adherence Rating Scale (MARS) 3 years MARS at baseline and then at exacerbation and annual visits. 5 Questions scored 1-5. 1 being the best and 5 being the worst.
The proportion of exacerbations associated with confrimed viral and bacterial infection 3 years The prercentage of participants within the cohort with at least one exacerbation associated with confirmed viral and bacterial infection by the end of the study
Induced sputum 3 years Induced sputum will be attempted on all patients at baseline exacerbation and on annual visits to assess sputum cell counts at each of the specific points.
Measuring Lung function and inflammation 3 years Measure Forced Oscialltion Technique (FOT) and Spirometry and Fractional Echaled Nitric Oxide (FENO) at baseline and then at exacerbation and annual visits.
Nasal lavage fluid and throat swab 3 years Nasal lavage will be performed along side a throat swab to identify any virsuses at baseline, exacerbation and annual visits.
Trial Locations
- Locations (1)
Nottingham respriatory research unit
🇬🇧Nottingham, Nottinghamshire, United Kingdom