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 @ 4:51 AM
Ignite Modification Date:
2025-12-25 @ 4:51 AM
NCT ID:
NCT00747318
Eligibility Criteria:
Inclusion Criteria:
* 1\. Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Day 1 (Baseline) visit and at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids). Subjects who enroll in this study SKY2028-3-006 immediately upon completion of study SKY2028-3-005 have automatically satisfied this criterion. Subjects who enroll in this study SKY2028-3-006 after completion of study SKY2028-3-005 within 24 weeks must use inhaled corticosteroid therapy at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids) for at least 4 weeks prior to the Day 1 (Baseline) visit.
* 2\. Females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test at the Day 1 Visit
* 3\. Subject is judged to be in good general health as determined by the investigator.
* 4\. Demonstrate satisfactory technique in the use of pMDI.
Exclusion Criteria:
* 1\. Subjects who prematurely discontinued from the study SKY2028-3-005.
* 2\. Life-threatening asthma within the past year.
* 3\. History of systemic (oral or injectable) corticosteroid use within the past 12 weeks,
* 4\. An upper or lower respiratory infection within 4 weeks prior to the Day 1 (Baseline) visit.
* 5\. Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis).
* 6\. Recent history of smoking, alcohol, substance abuse and/or psychiatric illness,
* 7\. Subjects who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past 1 week.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00747318
Study Brief:
Protocol Section:
NCT00747318