NCT00830102 - Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

January 31, 2005

Study Completion Date

January 31, 2005

Conditions

Asthma

Interventions

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)"

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)"

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)"

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)"

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)"

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)"

Trial Locations (6)

Unknown

Investigational site, Belfast

Investigational site, Derbyshire

Investigational site, London

Investigational site, Manchester

Investigational site, Plymouth

Investigational site, Slough

All Listed Sponsors

lead

SkyePharma AG

INDUSTRY