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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: SKP FlutiForm HFA pMDI

• Registration Number: NCT00747318
• Lead Sponsor: SkyePharma AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2011-06
• Disposition First Submitted: 2011-06-08
• Disposition First Submitted QC: 2011-06-08
• Last Update Submitted: 2011-06-08
• Disposition First Posted: 2011-06-23
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SKP FlutiForm HFA pMDI	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Investigational site; 🇺🇦 Zaporizhzhya, Ukraine

Investigational Site; 🇲🇽 Zapopan, Zapopan Jalisco, Mexico