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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT03858608
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015 with characteristic symptoms and at least one of the following:
• Reversible airflow limitation - 12% and 200ml increase in forced expiratory volume (FEV1) in the preceding 5 years either: i. After inhaled/nebulised bronchodilator or 4+ weeks of anti-inflammatory treatment ii. Between visits
• Positive bronchial challenge in the preceding 5 years: i. Provocation concentration (PC20) methacholine or histamine \<8mg/ml ii. Provocative dose (PD15) mannitol \<635mg
2. Difficult asthma defined as per Scottish Intercollegiate Guidelines Network (SIGN)/British Thoracic Society (BTS) guideline 2014 as persistent symptoms and/or frequent asthma attacks despite treatment at step 4 or step 5 with either:
* ACQ6 \>1.5
* ≥2 systemic corticosteroid boosts in previous year
* ≥1 hospitalization in previous year
3. BMI ≥ 30 kg/m2
Exclusion Criteria:
1. ICU admission +/- mechanical ventilation in the previous 6 months for asthma exacerbation
2. Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks
3. Significant respiratory or other co-morbidity likely to influence the conduct of the study
4. Pregnancy and breast feeding
5. Severe and/or unstable cardiac disease
6. Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or "Airsonett" device; eligible if on treatment for \> 6months or discontinued
7. Current insulin use
8. Current treatment with anti-obesity drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03858608
Study Brief:
Protocol Section:
NCT03858608