Official Title: “A Randomized, Placebo-Controlled, Double-Blind, Six-Way Crossover, Single-Dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10μg and 250/10μg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250μg) and Formoterol (12μg) Concurrently or Alone in Patients With Asthma”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: January 2005

Intervention(s) in this Clinical Trial

• 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)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 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
• Active Comparator: 2
  • 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
• Active Comparator: 3
  • 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
• Active Comparator: 4
  • 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
• Active Comparator: 5
  • 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
• Active Comparator: 6
  • 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

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs
  • Time Frame: 10 weeks including pre- and post-study assessments
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: SkyePharma AG

Overall Clinical Trial Officials and Contacts

SKP Study Director SkyePharma AG  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00830102

Study ID Number: SKY2028-2-001

ClinicalTrials.gov Identifier: NCT00830102

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency