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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: fluticasone propionate, formoterol fumarate

• Registration Number: NCT00830102
• Lead Sponsor: SkyePharma AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Status Verified: 2011-06
• Disposition First Submitted: 2011-06-08
• Disposition First Submitted QC: 2011-06-08
• Last Update Submitted: 2011-06-08
• Disposition First Posted: 2011-06-23
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4	fluticasone propionate, formoterol fumarate	* 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	fluticasone propionate, formoterol fumarate	* 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	fluticasone propionate, formoterol fumarate	* 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
1	fluticasone propionate, formoterol fumarate	* 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	fluticasone propionate, formoterol fumarate	* 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	fluticasone propionate, formoterol fumarate	* 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

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline	pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs	10 weeks including pre- and post-study assessments

Trial Locations

Locations (1)

Investigational site; 🇬🇧 Slough, United Kingdom