Trial | NCT00830102  Report issue

Title

Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients
A Randomized, Placebo-controlled, Double-blind, Six-way Crossover, Single-dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10μg and 250/10μg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250μg) and Formoterol (12μg) Concurrently or Alone in Patients With Asthma

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluticasone formoterol ...

  • Study Participants

    64
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.
Study Started
Oct 31
2004
Primary Completion
Jan 31
2005
Study Completion
Jan 31
2005
Last Update
Jun 23
2011
Estimate

Drug 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)

  • Other names: FlutiForm

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)

  • Other names: FlutiForm

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)

  • Other names: FlutiForm

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)

  • Other names: FlutiForm

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)

  • Other names: FlutiForm

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)

  • Other names: FlutiForm

1 Active Comparator

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

2 Active Comparator

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

3 Active Comparator

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

4 Active Comparator

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

5 Active Comparator

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

6 Active Comparator

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

Criteria 

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
No Results Posted