Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT04031261
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 quality of life scale, the Severe Asthma Questionnaire (SAQ).
To determine the Minimum Clinically Important Difference (MCID) of the SAQ
OUTCOME MEASURES
Questionnaires:
1. The Severe Asthma Questionnaire (SAQ)
2. The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
3. The EQ-5D-5L
4. The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ)
5. Global Rating of Change Questionnaire (GRCQ)
Clinical data comprises:
6. Spirometry
7. BMI
8. Asthma severity
9. Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the last 12 months;
10. Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if oral steroid dependent).
POPULATION All patients aged 16 years or over, who have attended one of three participating UK specialist asthma centres for the validation study and with data also collected from Derriford Hospital's Chest Clinic (DHCC) for use in determining Minimum clinically Important difference.
ELIGIBILITY Over 16 years of age Diagnosis of Severe Asthma
DURATION 18 months
Study:
NCT04031261
Study Brief:
Protocol Section:
NCT04031261