Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma

SkyePharma

Status and phase: Completed; Phase 2

Conditions: Mild to Moderate Asthma

Treatments: Other: fluticasone propionate, formoterol fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00734292

SKY2028-2-002

Details and patient eligibility

About

The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo.

Enrollment: 39 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid

Exclusion criteria

• Participation in a prior FlutiForm study
• Smoking history within the last 12 months,
• Significant, non-reversible, pulmonary disease
• Life-threatening asthma within the last year

Trial design

39 participants in 3 patient groups, including a placebo group

I

Placebo Comparator group

Description:

* Period 1 Treatment Regimen A: FlutiForm 250/10 ug * Period 2 Treatment Regimen B: FlutiForm 100/10 ug * Period 3 Treatment Regimen C: placebo

II

Placebo Comparator group

Description:

* Period 1 Treatment Regimen B: FlutiForm 100/10 ug * Period 2 Treatment Regimen C: placebo * Period 3 Treatment Regimen A: FlutiForm 250/10 ug

Treatment:

Other: fluticasone propionate, formoterol fumarate

Other: fluticasone propionate, formoterol fumarate

Other: fluticasone propionate, formoterol fumarate

III

Placebo Comparator group

Description:

* Period 1 Treatment Regimen C: placebo * Period 2 Treatment Regimen A: FlutiForm 250/10 ug * Period 3 Treatment Regimen B: FlutiForm 100/10 ug

Treatment:

Other: fluticasone propionate, formoterol fumarate

Other: fluticasone propionate, formoterol fumarate

Other: fluticasone propionate, formoterol fumarate