A Phase 3, Multicenter, Open-Label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005
Information source: SkyePharma AG
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: SKP FlutiForm HFA pMDI (Drug); salbutamol (albuterol) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: SkyePharma AG Official(s) and/or principal investigator(s):
Thao T Doan, MD, Study Director, Affiliation: Abbott Labs PPD R&D
Overall contact:
Karim N Sajwani, MS, CCRA, Phone: 847-937-4470, Email: karim.sajwani@abbott.com
Summary
The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA
pMDI 250/10 mg bid in adolescents and adults with moderate to severe asthma who have
completed the study SKY2028-3-005.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Primary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 12 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.
Locations and Contacts
Karim N Sajwani, MS, CCRA, Phone: 847-937-4470, Email: karim.sajwani@abbott.com
Investigational Site, Scottsdale, Arizona 85251, United States; Recruiting
Investigational Site
Investigational Site, Orange County, California 92868, United States; Recruiting
Investigational Site
Investigational Site, Colorado Springs, Colorado 80907, United States; Recruiting
Investigational Site
Investigational Site, Valrico, Florida 33596, United States; Recruiting
Investigational Site
Investigational Site, Elizabeth City, North Carolina 27909, United States; Recruiting
Investigational Site
Investigational Site, Portland, Oregon 97213, United States; Recruiting
Investigational Site
Investigational Site, Medford, Oregon 97504, United States; Recruiting
Investigational Site
Investigational Site, East Providence, Rhode Island 02914, United States; Recruiting
Investigational Site
Investigational Site, Providence, Rhode Island 02906, United States; Recruiting
Investigational Site
Investigational Site, West Allis, Wisconsin 53227, United States; Recruiting
Investigational Site
Additional Information
Starting date: September 2008
Ending date: March 2010
Last updated: September 4, 2008
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