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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

NCT ID: NCT00734292

Last Updated: 2010-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Mild to Moderate Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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I

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

Group Type PLACEBO_COMPARATOR

fluticasone propionate, formoterol fumarate

Intervention Type DRUG

● 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)

II

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

Group Type PLACEBO_COMPARATOR

fluticasone propionate, formoterol fumarate

Intervention Type OTHER

● 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)

III

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

Group Type PLACEBO_COMPARATOR

fluticasone propionate, formoterol fumarate

Intervention Type OTHER

● 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)

Interventions

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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)

Intervention Type DRUG

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)

Intervention Type 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)

Intervention Type OTHER

Other Intervention Names

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FlutiForm FlutiForm FlutiForm

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

SkyePharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

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SkyePharma AG

Locations

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Investigational Site

Anaheim, California, United States

Site Status

Investigational Site

Mission Viejo, California, United States

Site Status

Investigational Site

Denver, Colorado, United States

Site Status

Investigational Site

Valrico, Florida, United States

Site Status

Investigational Site

Medford, Oregon, United States

Site Status

Investigational Site

Portland, Oregon, United States

Site Status

Investigational Site

Richmond, Virginia, United States

Site Status

Investigational Site

West Allis, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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SKY2028-2-002

Identifier Type: -

Identifier Source: org_study_id

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