Clinical trial NCT00747318: A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Moderate to Severe
Lead sponsor: SkyePharma AG
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2008-09-05
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 SKY2028-3-005.


Eligibility 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 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.

Primary outcomes:
measure: 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
timeFrame: week 60
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigational Site
state: Arizona
city: Orange County
country: United States
facility: Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Investigational Site
state: Colorado
city: Valrico
country: United States
facility: Investigational Site
state: Florida
city: Elizabeth City
country: United States
facility: Investigational Site
state: North Carolina
city: Medford
country: United States
facility: Investigational Site
state: Oregon
city: Portland
country: United States
facility: Investigational Site
state: Oregon
city: East Providence
country: United States
facility: Investigational Site
state: Rhode Island
city: Providence
country: United States
facility: Investigational Site
state: Rhode Island
city: West Allis
country: United States
facility: Investigational Site
state: Wisconsin
city: Toluca
country: Mexico
facility: Investigational Site
state: Estado de Mexico
city: Guadalajara
country: Mexico
facility: Investigational Site
state: Jalisco
city: Villahermosa
country: Mexico
facility: Investigational Site
state: Tabasco Mexico
city: Zapopan
country: Mexico
facility: Investigational Site
state: Zapopan Jalisco
city: Mexico City
country: Mexico
facility: Investigational site
city: Lima
country: Peru
facility: Investigational site
city: Lima
country: Peru
facility: Investigational site
city: Lima
country: Peru
facility: Investigational site
city: Lima
country: Peru
facility: Investigational site
city: Lima
country: Peru
facility: Investigational site
city: Lima
country: Peru
facility: Investigational site
city: Constanta
country: Romania
facility: Investigational site
state: Jud. Constanta
city: Craiova
country: Romania
facility: Investigational site
state: Jud. Dolj
city: Timisoara
country: Romania
facility: Investigational site
state: Jud. Timis
city: Bucharest
country: Romania
facility: Investigational site
state: Sector 1
city: Bucharest
country: Romania
facility: Investigational site
state: Sector 3
city: Bucharest
country: Romania
facility: Investigational site
state: Sector 5
city: Dnipropetrovsk
country: Ukraine
facility: Investigational site
city: Dnipropetrovsk
country: Ukraine
facility: Investigational site
city: Donetsk
country: Ukraine
facility: Investigational site
city: Donetsk
country: Ukraine
facility: Investigational site
city: Kharkiv
country: Ukraine
facility: Investigational site
city: Kiev
country: Ukraine
facility: Investigational site
city: Kyiv
country: Ukraine
facility: Investigational site
city: Kyiv
country: Ukraine
facility: Investigational site
city: Kyiv
country: Ukraine
facility: Investigational site
city: Lviv
country: Ukraine
facility: Investigational site
city: Vinnytsya
country: Ukraine
facility: Investigational site
city: Zaporizhzhya
country: Ukraine
facility: Investigational site
Study officials:
affiliation: Abbott Labs PPD R&D
name: Thao T Doan, MD
role: STUDY_DIRECTOR
References: