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 @ 1:02 PM
Ignite Modification Date:
2025-12-24 @ 1:02 PM
NCT ID:
NCT01526161
Eligibility Criteria:
Inclusion Criteria:
* Children with physician diagnosed asthma aged 6 years -14 years, 11months
* Those requiring frequent short-acting beta2 agonist relief therapy ≥ 7 puffs in the past seven days
* Those with symptoms of asthma (i.e. wheeze, shortness of breath but not cough alone) resulting in:
i. Nocturnal wakening in the last week because of asthma symptoms and/or ii. Asthma has interfered with usual activities in the last week and/or iii. Those who have had exacerbations, defined as a short course of oral corticosteroids, an unscheduled GP or A\&E Department visit or a hospital admission within the previous 6 months
* Fully informed written (proxy) consent and assent, where appropriate
Exclusion Criteria:
* Children receiving long acting beta2-agonists, leukotriene receptor antagonists, regular theophylline therapy or high dose ICS \>1000micrograms and unlicensed beclometasone dipropionate or equivalent (at the discretion of the investigator)
* Children with other respiratory diseases, cystic fibrosis, cardiac disease or immunological disorders
* Non-English speaking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
14 Years
Study:
NCT01526161
Study Brief:
Protocol Section:
NCT01526161