Status:
COMPLETED
National Validation and Sensitivity to Change of the SAQ
Lead Sponsor:
University Hospital Plymouth NHS Trust
Collaborating Sponsors:
University of Plymouth
Conditions:
Asthma
Severe Asthma
Eligibility:
All Genders
16-100 years
Brief Summary
DESIGN A multi-centre mixed methods study of a new asthma specific quality of life questionnaire including limited clinic data. AIMS To collect further quantitative data to validate a new asthma qual...
Eligibility Criteria
Inclusion
- Part 1: National Validation
- All patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (GINA step 4 \& 5), and be aged 16 years or over.
Exclusion
- Patients that are unwilling to participate will be excluded from the study.
- In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma, which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe Chronic Obstructive Pulmonary Disease (COPD).
- The SAQ is currently only translated into British English. Therefore, if the participant is unable to read in English, they will be unable to participate.
- Part 2: Sensitivity to change
- Inclusion Criteria
- Patients commencing a biologic treatment for their severe asthma (GINA step 4 \& 5), as per NICE guidelines.
- Exclusion Criteria
- Patients will be excluded from the study if they are unwilling to participate
- In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe COPD.
Key Trial Info
Start Date :
April 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 23 2020
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT04031261
Start Date
April 10 2019
End Date
March 23 2020
Last Update
January 6 2021
Active Locations (5)
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1
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
2
Royal Devon & Exeter Hospital
Exeter, United Kingdom, EX2 5DW
3
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
4
Wythenshawe Hospital - Manchester
Manchester, United Kingdom, M23 9LT