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

Asthma Clinical Trial

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 and 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747318
• Other study ID #: SKY2028-3-006
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2008
• Last updated: June 8, 2011
• Start date: September 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2011
• Source: SkyePharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 SKY2028-3-005.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Mexico	Investigational Site	Guadalajara	Jalisco
Mexico	Investigational site	Mexico City
Mexico	Investigational Site	Toluca	Estado de Mexico
Mexico	Investigational Site	Villahermosa	Tabasco Mexico
Mexico	Investigational Site	Zapopan	Zapopan Jalisco
Peru	Investigational site	Lima
Peru	Investigational site	Lima
Peru	Investigational site	Lima
Peru	Investigational site	Lima
Peru	Investigational site	Lima
Peru	Investigational site	Lima
Romania	Investigational site	Bucharest	Sector 1
Romania	Investigational site	Bucharest	Sector 3
Romania	Investigational site	Bucharest	Sector 5
Romania	Investigational site	Constanta	Jud. Constanta
Romania	Investigational site	Craiova	Jud. Dolj
Romania	Investigational site	Timisoara	Jud. Timis
Ukraine	Investigational site	Dnipropetrovsk
Ukraine	Investigational site	Dnipropetrovsk
Ukraine	Investigational site	Donetsk
Ukraine	Investigational site	Donetsk
Ukraine	Investigational site	Kharkiv
Ukraine	Investigational site	Kiev
Ukraine	Investigational site	Kyiv
Ukraine	Investigational site	Kyiv
Ukraine	Investigational site	Kyiv
Ukraine	Investigational site	Lviv
Ukraine	Investigational site	Vinnytsya
Ukraine	Investigational site	Zaporizhzhya
United States	Investigational Site	Colorado Springs	Colorado
United States	Investigational Site	East Providence	Rhode Island
United States	Investigational Site	Elizabeth City	North Carolina
United States	Investigational Site	Medford	Oregon
United States	Investigational Site	Orange County	California
United States	Investigational Site	Portland	Oregon
United States	Investigational Site	Providence	Rhode Island
United States	Investigational Site	Scottsdale	Arizona
United States	Investigational Site	Valrico	Florida
United States	Investigational Site	West Allis	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
SkyePharma AG	Abbott

Countries where clinical trial is conducted

United States,  Mexico,  Peru,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		week 60	No