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

SkyePharma

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: fluticasone propionate, formoterol fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00830102

SKY2028-2-001

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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64 participants in 6 patient groups

1

Active Comparator group

Description:

* 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

Treatment:

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

2

Active Comparator group

Description:

* 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

Treatment:

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

3

Active Comparator group

Description:

* 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

Treatment:

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

4

Active Comparator group

Description:

* 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

Treatment:

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

5

Active Comparator group

Description:

* 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

Treatment:

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

6

Active Comparator group

Description:

* 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

Treatment:

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate

Drug: fluticasone propionate, formoterol fumarate