Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT04031261
Eligibility Criteria:
Part 1: National Validation
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
100 Years
Study:
NCT04031261
Study Brief:
Protocol Section:
NCT04031261