None listed
Conditions
Interventions
Each subject will receive SKP FlutiForm HFA pMDI 250/10 microgram twice daily for 60 weeks (two actuations of SKP FlutiForm HFA pMDI 125/5 microgram/actuation) for a total daily dose of 500 microgram fluticasone propionate and 20 microgram formoterol fumarate.
Sponsors
ABOTT RESPIRATORY LLC,
Eligibility
Sex/Gender
All
Age
12 Years to 90 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:Safety Timepoints:Week 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:No Information Measure:No Information Timepoints:No Information | — |
Countries
Mexico, Peru, Romania, Ukraine, United States
Outcome results
None listed