NCT00734292

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

A Randomized, Placebo-controlled, Double-blind, Crossover, Single-dose Exposure Study to Evaluate the Early Bronchodilating Effect of FlutiForm 100/10 µg HFA pMDI and FlutiForm 250/10 µg HFA pMDI, Compared to Placebo in Adult Subjects With Mild to Moderate Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: SkyePharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Mild to Moderate Asthma

Interventions

Type	Name	Description
DRUG	fluticasone propionate, formoterol fumarate	● 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)
OTHER	fluticasone propionate, formoterol fumarate	● 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)
OTHER	fluticasone propionate, formoterol fumarate	● Period 1 Treatment Regimen C: placebo SKP placebo; (two actuations) ● Period 2 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) ● Period 3 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2008-08-14
• Last updated: 2010-08-27

Locations

8 sites across 1 country: United States