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

SkyePharma

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: SKP FlutiForm HFA pMDI

Study type

Interventional

Funder types

Industry

Identifiers

NCT00747318

SKY2028-3-006

Details and patient eligibility

About

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.

Enrollment

280 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
1. Females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test at the Day 1 Visit
1. Subject is judged to be in good general health as determined by the investigator.
1. Demonstrate satisfactory technique in the use of pMDI.

Exclusion criteria

1. Subjects who prematurely discontinued from the study SKY2028-3-005.
1. Life-threatening asthma within the past year.
1. History of systemic (oral or injectable) corticosteroid use within the past 12 weeks,
1. An upper or lower respiratory infection within 4 weeks prior to the Day 1 (Baseline) visit.
1. Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis).
1. Recent history of smoking, alcohol, substance abuse and/or psychiatric illness,
1. 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.