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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT05613803
Eligibility Criteria:
Inclusion Criteria:
1. aged ≥18 years. N-ERD does not occur at birth and it rarely occurs in children.
2. physician labelled diagnosis of asthma.
3. history of N-ERD according EAACI guidelines(9) with evidence of one of 1) Clinical diagnosis as evidence by i. A reliable history of aspirin or NSAID induced respiratory reaction as evidenced by more than one reaction, reactions to two or more different NSAIDs or the last reaction occurring within the last 5 years plus ii. Recurrent nasal polyposis, anosmia, moderate to severe asthma, intolerance to alcohol and/or blood eosinophilia 2) Positive nasal or bronchial aspirin challenge(43)
4. ACQ of more than 1.5 as this indicates poor control. This is required to ensure there is a clinical need or a requirement to alter medication.
5. stable disease, as evidenced by a lack of change in asthma therapy within the last 6 weeks.
Exclusion Criteria:
1. significant cardiac disease, respiratory disease or other cause for breathlessness other than asthma
2. severe or uncontrolled co-morbid disease (other than nasal polyps) which is likely to affect the outcome of the study
3. having had an upper or lower respiratory tract infection requiring antibiotics within four weeks of randomisation
4. receiving aspirin desensitisation therapy or biologic agents
5. receiving n-3 fatty acid oral supplements
6. current smoker or more than 15 pack-year smoking history
7. consumption of more than 21 units of alcohol per week as alcohol-induced respiratory symptoms are more common in N-ERD.
8. patients unable to give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05613803
Study Brief:
Protocol Section:
NCT05613803