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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT01772368
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent/assent
* General good health
* Diagnosis of asthma as defined by the National Institutes of Health (NIH)
* A best FEV1 of 40%-85% of the predicted normal value during the screening visit (SV)
* Subjects need to demonstrate a ≥ 15% reversibility of FEV1 within 30 minutes following 4 inhalations of albuterol inhalation aerosol (if required, spacers are permitted for reversibility testing) at the SV.
* Other inclusion criteria apply
Exclusion Criteria:
* History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
* Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the SV.
* Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
* Taking long-acting β-agonists within 2 weeks of the SV
* Other exclusion criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01772368
Study Brief:
Protocol Section:
NCT01772368