Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
SkyePharma AG
ClinicalTrials.gov Identifier:
NCT00830102
First received: January 26, 2009
Last updated: June 8, 2011
Last verified: June 2011

January 26, 2009
June 8, 2011
October 2004
January 2005   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00830102 on ClinicalTrials.gov Archive Site
Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs [ Time Frame: 10 weeks including pre- and post-study assessments ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • 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)
    Other Names:
    • FlutiForm
    • fluticasone propionate, formoterol fumarate
  • 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)
    Other Names:
    • FlutiForm
    • fluticasone propionate, formoterol fumarate
  • 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)
    Other Names:
    • FlutiForm
    • fluticasone propionate, formoterol fumarate
  • 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)
    Other Names:
    • FlutiForm
    • fluticasone propionate, formoterol fumarate
  • 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)
    Other Names:
    • FlutiForm
    • fluticasone propionate, formoterol fumarate
  • 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)
    Other Names:
    • FlutiForm
    • fluticasone propionate, formoterol fumarate
  • 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
    Intervention: Drug: fluticasone propionate, formoterol fumarate
  • 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
    Intervention: Drug: fluticasone propionate, formoterol fumarate
  • 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
    Intervention: Drug: fluticasone propionate, formoterol fumarate
  • 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
    Intervention: Drug: fluticasone propionate, formoterol fumarate
  • 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
    Intervention: Drug: fluticasone propionate, formoterol fumarate
  • 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
    Intervention: Drug: fluticasone propionate, formoterol fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   United Kingdom
 
NCT00830102
SKY2028-2-001
No
SkyePharma AG
SkyePharma AG
Not Provided
Study Director: SKP SkyePharma AG
SkyePharma AG
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP