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 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT01286532
Eligibility Criteria:
Inclusion Criteria:
* Child (male or female) aged 5 to 11 years inclusive
* Provision of Subject Informed Consent Form for anonymous data collection and their subsequent use (must be signed by any of the parents)
* The child must be included in an out-patient observation program at a medical institution for established bronchial asthma diagnosis for at least 1 year prior to enrolment and diagnosed with moderate to severe bronchial asthma at the time of enrolment
* The child must have at least one documented bronchial asthma exacerbation in previous 1 year (including hospital admissions for bronchial asthma exacerbations, any cases of daytime hospital treatment without overnight stays and any cases of oral administration of glucocorticoids on an out-patient basis for \> 3 consecutive days)
* Out-patient receiving step 3 controller treatments with fixed dose combinations of ICSs and LABA or treatment with separate administration of glucocorticoids and LABA in stable doses with adequate control of bronchial asthma symptoms
* The patient administered with short-acting β2 agonists (inhalational) or rapidly released methylxanthines (oral) in the doses approved for the respective age as a rescue on-demand therapies during the preceding month
Exclusion Criteria:
* Cystic fibrosis, α1-antitrypsin deficiency or congenital abnormalities of lung development
* Severe comorbidities affecting the patient's overall performance
* In the physician's opinion, the patient is not able to comply with the protocol requirements
* Expected specific hyposensibilization within next 6 months
* Expected treatment at health resort facilities within next 6 months
* Other reasons that in the physician's opinion will prevent reliable assessments of the study treatment efficacy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
11 Years
Study:
NCT01286532
Study Brief:
Protocol Section:
NCT01286532