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

SkyePharma AG64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

fluticasone propionate, formoterol fumarateDRUG

* 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)

fluticasone propionate, formoterol fumarateDRUG

* 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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (6)

Investigational site

Belfast, Ireland

Investigational site

Derbyshire, United Kingdom

Investigational site

London, United Kingdom

Investigational site

Manchester, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 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 Outcomes

Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs

Time frame: 10 weeks including pre- and post-study assessments

Data from ClinicalTrials.gov

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