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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

S

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

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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