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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT01848769
Eligibility Criteria:
Inclusion Criteria:
* Male/Female children aged 5-11 years
* Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
* children with stable asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
* Forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period.
6\. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.
Exclusion Criteria:
* Past or present diagnoses of cardiovascular, renal or liver disease
* Known hypersensitivity to the active treatments
* Exacerbation of asthma symptoms within the previous 4 weeks
* Inability to perform the required breathing technique and blood sampling
* Hospitalization due to exacerbation of asthma within 1 month prior to inclusion
* Lower respiratory tract infection within 1 month prior to inclusion
* Disease (other than asthma) which might influence the outcome of the study
* Obesity, i.e. \> 97% weight percentile by local standards
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
11 Years
Study:
NCT01848769
Study Brief:
Protocol Section:
NCT01848769