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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT03269318
Eligibility Criteria:
Inclusion Criteria:
* Parent/Guardian/Participant is willing and able to give informed consent/assent
* Physician-diagnosed asthma that is inadequately controlled as per view of doctor (for example, history of at least two emergency visits to GP or hospital over the previous year, frequent use of blue inhaler (three times or more per week))
* Aged 5-11 years (inclusive)
* Children who are already on at least 400 micrograms per day inhaled beclomethasone or equivalent and hence ready to be prescribed inhaled long-acting beta2 agonists and/or other add-on medication or are already on inhaled long-acting beta2 agonists and/or other add-on medication
Exclusion Criteria:
* Parent/Guardian/Participant is unwilling or unable to give informed consent/assent
* Known contraindication to montelukast or salmeterol
* Other known significant airway or lung disease (e.g. chronic lung disease of prematurity, cystic fibrosis or congenital airway abnormalities) or other co-existing serious disease such as congenital cardiac disease
* Poor inhaler technique and/or history of poor adherence on checking following standard procedure at the clinic
* Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
11 Years
Study:
NCT03269318
Study Brief:
Protocol Section:
NCT03269318