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:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01730027
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 years to 50 years (inclusive)
* Diagnosis of asthma (GINA 2011) including a demonstration of reversible airway obstruction
* Pre-bronchodilator FEV1 value ≥ 40% and ≤ 85% of the predicted normal value at baseline
* A score of 1.5 or greater on the Asthma Control Questionnaire at baseline
* Daily use of low to moderate dose of ICS (equivalent to budesonide ≤ 800 µg per day)
* Prescribed a short-acting inhaled bronchodilator as reliever therapy for relief of symptoms
* A peripheral blood eosinophil count ≥ 0.25 x 109/L
* Non-smoker or former smoker who has not smoked in the last six months
* Body mass index (BMI) ≥ 17 and ≤ 35 kg/m2
* Able to comply with the protocol requirements, instructions and restrictions
* Able to provide signed and dated written informed consent
Exclusion Criteria:
* Subjects with severe asthma exacerbation in the 4 weeks prior to consent
* Subjects with respiratory tract infection in the 4 weeks prior to consent
* Subjects with COPD or other relevant lung diseases
* Subjects with clinically significant condition which may compromise subject safety or interfere with study evaluation
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01730027
Study Brief:
Protocol Section:
NCT01730027