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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT01142505
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 10 months and ≤ 5 years old on the day of the first dose of Investigational Medicinal Product
* two or more attacks of parent-reported wheeze
* at least one attack with wheeze validated by a clinician
* the most recent attack within the last 3 months
* contactable by telephone and able to attend one face-to-face review for issue of Investigational Medicinal Product
* parent or guardian able to give written informed consent for their child to participate in the study
Exclusion Criteria:
* any other chronic respiratory condition diagnosed by a clinician including structural airway abnormality (e.g. floppy larynx) and cystic fibrosis
* any chronic condition that increases vulnerability to respiratory tract infection such as severe developmental delay with feeding difficulty
* history of neonatal chronic lung disease
* current continuous oral montelukast therapy
* in a trial using an Investigational Medicinal Product in the previous 3 months prior to recruitment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Months
Maximum Age:
5 Years
Study:
NCT01142505
Study Brief:
Protocol Section:
NCT01142505