A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005

Completed · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID: NCT00747318
Run by: SkyePharma AG
People needed: 280
Starts: 2008-09-01
Expected to finish: 2010-06-01
Last updated by the study team: 2011-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Investigational Site — Scottsdale, Arizona, United States
Investigational Site — Orange County, California, United States
Investigational Site — Colorado Springs, Colorado, United States
Investigational Site — Valrico, Florida, United States
Investigational Site — Elizabeth City, North Carolina, United States
Investigational Site — Medford, Oregon, United States
Investigational Site — Portland, Oregon, United States
Investigational Site — East Providence, Rhode Island, United States
Investigational Site — Providence, Rhode Island, United States
Investigational Site — West Allis, Wisconsin, United States
Investigational Site — Guadalajara, Jalisco, Mexico
Investigational site — Mexico City, Mexico City, Mexico
Investigational Site — Toluca, State of Mexico, Mexico
Investigational Site — Villahermosa, Tabasco Mexico, Mexico
Investigational Site — Zapopan, Zapopan Jalisco, Mexico
Investigational site — Lima, Lima Province, Peru
Investigational site — Lima, Lima Province, Peru
Investigational site — Lima, Lima Province, Peru
Investigational site — Lima, Lima Province, Peru
Investigational site — Lima, Lima Province, Peru
Investigational site — Lima, Lima Province, Peru
Investigational site — Constanța, Jud. Constanta, Romania
Investigational site — Craiova, Jud. Dolj, Romania
Investigational site — Timișoara, Jud. Timis, Romania
Investigational site — Bucharest, Sector 1, Romania

Full record on ClinicalTrials.gov

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