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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01435902
Eligibility Criteria:
Inclusion Criteria:
* Outpatient male or female 12 to 50 years of age
* Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
* Diagnosis of persistent asthma for at least 6 months
* Best pre-bronchodilator FEV1 of at least 70%.
* Current use of a low- to moderate-dose inhaled corticosteroid
* Ability to withhold albuterol 6 hours prior to visits.
* Physically able to perform exercise testing on a treadmill when albuterol has been withheld
Exclusion Criteria:
* Intermittent asthma, seasonal asthma, or exercise-induced asthma only
* Symptomatic allergic rhinitis and/or thrush
* Abnormal, clinically significant electrocardigraph
* Respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
* Asthma exacerbation within 12 weeks of first visit
* Respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
* Investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
* Allergy to study drugs or study drug excipients
* Concomitant medications that could interact with study medications or affect the course of asthma
* Tobacco use within last year and/or a 10 pack-years history
* Inability to comply with requirements of the study
* Affiliation with investigator's site (example: family member)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
50 Years
Study:
NCT01435902
Study Brief:
Protocol Section:
NCT01435902