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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT02787967
Eligibility Criteria:
Inclusion Criteria:
* Male/female children with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
* Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.
* Age ≥ 5 \< 12 years (8 to 10 children in the age range 5-8 years old).
* Children with a forced expiratory volume in one second (FEV1)\>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
* A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures
Exclusion Criteria:
* Past or present diagnosis of cardiovascular, renal or liver disease.
* Known hypersensitivity to the active treatmen
* Exacerbation of asthma symptoms within 4 weeks prior to screening.
* Inability to perform the required breathing technique and blood sampling.
* Hospitalization due to exacerbation of asthma within 1 month prior to screening (Visit 1).
* Lower respiratory tract infection within 1 month prior to screening (Visit 1).
* 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:
NCT02787967
Study Brief:
Protocol Section:
NCT02787967