A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005
This study has been completed.
Information provided by:
First received: September 4, 2008
Last updated: June 8, 2011
Last verified: June 2011
The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005.
Drug: SKP FlutiForm HFA pMDI
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005, Incorporating Amendment 1 and 2
Primary Outcome Measures:
- To assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005 [ Time Frame: week 60 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2010 (Final data collection date for primary outcome measure)
Drug: SKP FlutiForm HFA pMDI
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.
- fluticasone propionate/formoterol fumarate
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00747318
||Thao T Doan, MD
||Abbott Labs PPD R&D
No publications provided
||Kirsten Kaiser, MD, SkyePharma AG
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 4, 2008
||June 8, 2011
||United States: Food and Drug Administration
Keywords provided by SkyePharma AG:
ClinicalTrials.gov processed this record on March 25, 2015