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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT01476904
Eligibility Criteria:
Inclusion Criteria:
* Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation
* Male and female asthma patients aged 12 - 75 years
* Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment
* No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening
* Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter
* Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study
Exclusion Criteria:
* A smoking history of 10-pack years, or having smoked within 12 months of screening
* Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma
* Concurrent clinically significant diseases
* Known intolerance or hypersensitivity to any component of the study drugs
* Recent infection of the respiratory tract, before screening
* Use of prohibited medications
* Having been on other investigational drug/device studies in the last 30 days prior to screening
* Known or highly suspected substance abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
75 Years
Study:
NCT01476904
Study Brief:
Protocol Section:
NCT01476904