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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT01475032
Eligibility Criteria:
Inclusion Criteria:
* Male and female children (aged ≥ 5 and \< 12 years)
* Partly controlled asthma children according to Global Initiative for Asthma guidelines (GINA)
* Symptomatic asthmatic patients treated with BDP up to 400 micrograms or equivalent
* FEV1 ≥ 60% and ≤ 95% of predicted normal values
Exclusion Criteria:
* Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever.
* Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks before study entry
* History of near fatal asthma
* History of cystic fibrosis, bronchiectasis or primary ciliary dyskinesia
* Diagnosis of restrictive lung disease.
* Patients treated with systemic corticosteroids
* Significant medical history and/or treatments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
11 Years
Study:
NCT01475032
Study Brief:
Protocol Section:
NCT01475032