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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT00462592
Eligibility Criteria:
Inclusion Criteria:
* Males or females ages 8-35 years with stable mild-to-moderate asthma (ATS criteria) not on regular controller therapy
* Prebronchodilator FEV1 predicted ≥ 70%
* No other medical co-morbidity
* Demonstrate maxFEV1% ≥15% on exercise challenge at screening and 1 week post run-in.
Exclusion Criteria:
* Asthma exacerbations or respiratory infection within 4 weeks of screening
* Recent use of inhaled or systemic steroids
* Immunosuppressives
* Antihistamines, NSAIDs and investigational drugs within 30 days
* Unable to reliably perform spirometry and exercise challenge
* Current or ex-smokers ≥ 10 pack-years and less than 1 month abstinence
* Contra-indications to inhaled steroids or montelukast use.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
35 Years
Study:
NCT00462592
Study Brief:
Protocol Section:
NCT00462592