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Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients

NCT ID: NCT00830102

Last Updated: 2011-06-23

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-01-31

Brief Summary

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The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

* Period 1 Treatment Regimen A: FlutiForm 100/10 ug
* Period 2 Treatment Regimen B: FlutiForm 250/10 ug
* Period 3 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug
* Period 4 Treatment Regimen D: Flixotide Evohaler 250 ug

Group Type ACTIVE_COMPARATOR

fluticasone propionate, formoterol fumarate

Intervention Type DRUG

* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol 12 ug)
* Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI
* Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
* Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)

2

* Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug
* Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug
* Period 3 Treatment Regimen B: FlutiForm 250/10 ug
* Period 4 Treatment Regimen A: FlutiForm 100/10 ug

Group Type ACTIVE_COMPARATOR

fluticasone propionate, formoterol fumarate

Intervention Type DRUG

* Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation)
* Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
* Period 3 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)
* Period 4 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)

3

* Period 1 Treatment Regimen B: FlutiForm 250/10 ug
* Period 2 Treatment Regimen A: FlutiForm 100/10 ug
* Period 3 Treatment Regimen F: Placebo
* Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug

Group Type ACTIVE_COMPARATOR

fluticasone propionate, formoterol fumarate

Intervention Type DRUG

* Period 1 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)
* Period 2 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
* Period 3 Treatment Regimen F: Placebo (Two actuations of placebo HFA pMDI)
* Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)

4

* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug
* Period 2 Treatment Regimen F: Placebo
* Period 3 Treatment Regimen A: FlutiForm 100/10 ug
* Period 4 Treatment Regimen B: FlutiForm 250/10 ug

Group Type ACTIVE_COMPARATOR

fluticasone propionate, formoterol fumarate

Intervention Type DRUG

* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
* Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)
* Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
* Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)

5

* Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug
* Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug
* Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug
* Period 4 Treatment Regimen F: Placebo

Group Type ACTIVE_COMPARATOR

fluticasone propionate, formoterol fumarate

Intervention Type DRUG

* Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
* Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125 ug/actuation)
* Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
* Period 4 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)

6

* Period 1 Treatment Regimen F: Placebo
* Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug
* Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug
* Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug

Group Type ACTIVE_COMPARATOR

fluticasone propionate, formoterol fumarate

Intervention Type DRUG

* Period 1 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI
* Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
* Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA MDI 125 ug)
* Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)

Interventions

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fluticasone propionate, formoterol fumarate

* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol 12 ug)
* Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI
* Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
* Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)

Intervention Type DRUG

fluticasone propionate, formoterol fumarate

* Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation)
* Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
* Period 3 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)
* Period 4 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)

Intervention Type DRUG

fluticasone propionate, formoterol fumarate

* Period 1 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)
* Period 2 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
* Period 3 Treatment Regimen F: Placebo (Two actuations of placebo HFA pMDI)
* Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)

Intervention Type DRUG

fluticasone propionate, formoterol fumarate

* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
* Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)
* Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
* Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)

Intervention Type DRUG

fluticasone propionate, formoterol fumarate

* Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
* Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125 ug/actuation)
* Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
* Period 4 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)

Intervention Type DRUG

fluticasone propionate, formoterol fumarate

* Period 1 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI
* Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
* Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA MDI 125 ug)
* Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)

Intervention Type DRUG

Other Intervention Names

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FlutiForm FlutiForm FlutiForm 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

* Smoking history within the last 12 months
* No history of respiratory tract infection within 4 weeks
* No history or evidence of any clinically significant disease or abnormality
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SkyePharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

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SkyePharma AG

Principal Investigators

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SKP

Role: STUDY_DIRECTOR

SkyePharma AG

Locations

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Investigational site

Belfast, , Ireland

Site Status

Investigational site

Derbyshire, , United Kingdom

Site Status

Investigational site

London, , United Kingdom

Site Status

Investigational site

Manchester, , United Kingdom

Site Status

Investigational site

Plymouth, , United Kingdom

Site Status

Investigational site

Slough, , United Kingdom

Site Status

Countries

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Ireland United Kingdom

Other Identifiers

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SKY2028-2-001

Identifier Type: -

Identifier Source: org_study_id

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