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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06360185
Other study ID # Asthma V2 October 2023
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date December 1, 2025

Study information

Verified date March 2024
Source Norfolk and Norwich University Hospitals NHS Foundation Trust
Contact Sadiyah Hand, FRPC
Phone 01603 289612
Email sadiyah.hand@nnuh.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study team will obtain a list of all patients who have been seen in A+E over the past 6 years with a discharge diagnosis of asthma. Their history will be reviewed from their A+E notes. Team will obtain weight and height from Electronic prescribing tool and will obtain compliance information and past medical history from participant's GP records. Team will use participant's postcode to word out socio economic status quintile using office of national statistics tool. The following information will be taken from hospital documentation and from GP records.


Description:

1. How many previous admissions in past one year (12 months) 2. How many presentations to A+E in previous one year (12 months) 3. Diagnosis not confirmed therefore not on any ICS 4. Poor compliance (less than 75% of ICS and/or LABA and/or LAMA and/or leukotriene prescriptions picked up in past year) 5. Recent presentation and maintenance therapy not increased (primary care or secondary care issue) 6. Is patient overweight BMI 7. Is patient on hormonal therapy, OCP, HRT, male hormones 8. Social class quintile from post code of address using ONS calculator 9. Ethnically diverse (see appendix) 10. First Eosinophil count on index admission 11. Highest eosinophil count in past (ever) and date 12. Treatment for diabetes type 2 13. Treatment for diabetes type 1 14. Treatment for hypertension 15. Smoker ever (pack year) when gave up__________ After obtaining this information study team will use simple statistical methods such as frequency and associations with confidence intervals to investigate which factors are associated with frequency of presentation to A+E. They will ascertain the frequency of patients who are on maximum therapy and may benefit from biological therapy, especially if they have raised eosinophils in the past year.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers
Gender All
Age group 16 Years to 99 Years
Eligibility Inclusion Criteria: - All Asthmatics patients who attend Emergency department over 5 years Exclusion Criteria: - None Asthmatics.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary Change in body weight Information will be taken from hospital documentation and from GP records. 5 years
Primary Change in body height Information will be taken from hospital documentation and from GP records. 5 years
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