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

SkyePharma AG39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Mild to Moderate Asthma

Interventions

fluticasone propionate, formoterol fumarateDRUG

● Period 1 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) ● Period 2 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) ● Period 3 Treatment Regimen C: placebo SKP placebo; (two actuations)

fluticasone propionate, formoterol fumarateOTHER

● Period 1 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) ● Period 2 Treatment Regimen C: placebo SKP placebo; (two actuations) ● Period 3 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)

fluticasone propionate, formoterol fumarate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Investigational Site

Anaheim, California, United States

Investigational Site

Mission Viejo, California, United States

Investigational Site

Denver, Colorado, United States

Investigational Site

Valrico, Florida, United States

Outcomes

Primary Outcomes

Change from baseline FEV1 to post study drug dosing FEV1

Time frame: 3 minutes

Secondary Outcomes

Change from baseline FEV1 to post study drug dosing FEV1

Time frame: 8, 15, 30, and 60 minutes

Data from ClinicalTrials.gov

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