A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005
- Conditions
- -J45J45
- Registration Number
- PER-118-08
- Lead Sponsor
- ABOTT RESPIRATORY LLC,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• 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.
• Females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test at the Day 1 Visit
• Subject is judged to be in good general health as determined by the investigator.
• Demonstrate satisfactory technique in the use of pMDI.
• Subjects who prematurely discontinued from the study SKY2028-3-005.
• Life-threatening asthma within the past year.
• History of systemic (oral or injectable) corticosteroid use within the past 12 weeks,
• An upper or lower respiratory infection within 4 weeks prior to the Day 1 (Baseline) visit.
• Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis).
• Recent history of smoking, alcohol, substance abuse and/or psychiatric illness,
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The safety variables will be evaluated throughout the study through monthly telephone contacts and study visits every 3 months. Safety variables will include AE, serious adverse events (SAE), laboratory data, vital signs and ECG.<br>Measure:Safety<br>Timepoints:Week 60<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:No Information<br>Measure:No Information<br>Timepoints:No Information<br>