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

Sponsor:	SkyePharma AG
Information provided by:	SkyePharma AG
ClinicalTrials.gov Identifier:	NCT00830102

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 II

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

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Fluticasone propionate Fluticasone Arformoterol Tartrate

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
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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)
2: Active Comparator 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)
3: Active Comparator 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)
4: Active Comparator 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)
5: Active Comparator 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)
6: Active Comparator 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)

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
London, United Kingdom
Investigational site
Manchester, United Kingdom
Investigational site
Plymouth, United Kingdom
Investigational site
Slough, United Kingdom
Investigational site
Derbyshire, United Kingdom

Sponsors and Collaborators

SkyePharma AG

Investigators

Study Director:

SKP

SkyePharma AG

More Information

No publications provided

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

Keywords provided by SkyePharma AG:

Mild to Moderate Asthma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Formoterol

Dermatologic Agents
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010