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

NCT00734292 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2010-08-27

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • SkyePharma AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-09-30
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00734292 on ClinicalTrials.gov