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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

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: fluticasone propionate, formoterol fumarate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by SkyePharma AG:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: October 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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
 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
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
 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
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
 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
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
 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
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
 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830102

Locations
Ireland
Investigational site
Belfast, Ireland
United Kingdom
Investigational site
Derbyshire, United Kingdom
Investigational site
London, United Kingdom
Investigational site
Manchester, United Kingdom
Investigational site
Plymouth, United Kingdom
Investigational site
Slough, United Kingdom
Sponsors and Collaborators
SkyePharma AG
Investigators
Study Director: SKP SkyePharma AG
  More Information

No publications provided

Responsible Party: SkyePharma AG
ClinicalTrials.gov Identifier: NCT00830102     History of Changes
Other Study ID Numbers: SKY2028-2-001
Study First Received: January 26, 2009
Last Updated: June 8, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by SkyePharma AG:
Mild to Moderate Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on October 18, 2012