Status:
COMPLETED
A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005
Lead Sponsor:
SkyePharma AG
Collaborating Sponsors:
Abbott
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 SK...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00747318
Start Date
September 1 2008
End Date
June 1 2010
Last Update
June 23 2011
Active Locations (39)
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1
Investigational Site
Scottsdale, Arizona, United States, 85251
2
Investigational Site
Orange County, California, United States, 92868
3
Investigational Site
Colorado Springs, Colorado, United States, 80907
4
Investigational Site
Valrico, Florida, United States, 33596