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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT00130351
Eligibility Criteria:
Inclusion Criteria:
* Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary
* Patients who have a current diagnosis of asthma
* Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a \>12% increase in FEV1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at Visit 1. The administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry.
Exclusion Criteria:
* Patients who were enrolled in study CFOR258F2304 or CFOR258F2306, or who have any experience using the Certihaler® device.
* QTc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ECG) that in the opinion of the investigator would present a safety hazard for continuation in the study
* Patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies
* Other protocol-defined inclusion and exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT00130351
Study Brief:
Protocol Section:
NCT00130351