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Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
This study has been completed.
First Received: October 27, 2006   Last Updated: May 27, 2008   History of Changes
Sponsor: SkyePharma AG
Information provided by: SkyePharma AG
ClinicalTrials.gov Identifier: NCT00394199
  Purpose

To compare the efficacy and safety of the fixed combination asthma drug Flutiform HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, in adult and adolescent patients with mild to moderate asthma.


Condition Intervention Phase
Asthma
Drug: Fluticasone propionate/Formoterol Fumarate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Active-Controlled, Parallel Group, Stratified, Multi-Center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm) 100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & Adult Patients With Mild to Moderate Asthma

Resource links provided by NLM:


Further study details as provided by SkyePharma AG:

Primary Outcome Measures:
  • Change in Forced Expiratory volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary

Secondary Outcome Measures:
  • Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR).
  • Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).
  • Safety variables include adverse events, ECGs, clinical laboratory tests and vital signs.

Estimated Enrollment: 350
Study Start Date: June 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Ages eligible for study: 12 years and above
  • Genders eligible for study: both
  • Prior steriod use: steroid-requiring or steroid-free

Inclusion Criteria:

  • History of asthma for at least 12 months
  • For steriod-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit
  • For steroid-free patients, no history of inhaled steroid asthma medication for at least 12 weeks prior to Screening Visit
  • Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline Visit
  • Documented reversibility of 15% within 12 months of Screening or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or neubulized albuterol administration)
  • Symptoms of asthma during Run-in
  • Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either sterile, or using acceptable methods of contraception.
  • Must otherwise be healthy
  • Provide written informed consent. Wishes of minors must be respected.

Exclusion Criteria:

Patients will not be eligible for the study if they meet any of the following criteria:

  • Life-threatening asthma within the past year or during the Run-In Period.
  • History of systemic corticosteroid medication within 3 months before the Screening Visit.
  • History of omalizumab use within past 6 months.
  • History of leukotriene receptor antagonist use, e.g., montelukast, within past week.
  • Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
  • Upper or lower respiratory infection within 4 weeks prior to Screening Visit or during Run-In Period.
  • Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis).
  • Known Human Immunodeficiency Virus (HIV)-positive status.
  • Smoking history equivalent to "10 pack years".
  • Current smoking history within 12 months prior to Screening Visit.
  • Current evidence or history of alcohol and/or substance abuse within 12 months prior to Screening Visit.
  • Patients who are confined in institution.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394199

  Hide Study Locations
Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35242
United States, California
Research Site
Orange, California, United States, 92868
Research Site
San Jose, California, United States, 95117
Research Site
Vista, California, United States, 92083
Research Site
Mission Viejo, California, United States, 92691
United States, Colorado
Research Site
Denver, Colorado, United States, 80230
United States, Georgia
Research Site
Lilburn, Georgia, United States, 30047
Research Site
Savannah, Georgia, United States, 31406
United States, Kansas
Research Site
Park City, Kansas, United States, 67219
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Research Site
N. Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Research Center
Stevensville, Michigan, United States, 49127
United States, New Jersey
Research Site
Elizabeth, New Jersey, United States, 07202
United States, New York
Research Center
Rochester, New York, United States, 14618
United States, North Carolina
Research Site
Asheville, North Carolina, United States, 28801
Research Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45242
Research Site
Sylvania, Ohio, United States, 43560
United States, Pennsylvania
Research Site
Easton, Pennsylvania, United States, 18045
United States, Rhode Island
Research Site
Lincoln, Rhode Island, United States, 02906
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States, 37421
United States, Texas
Research Site
Katy, Texas, United States, 77450
Research Site
Waco, Texas, United States, 76712
Research Site
New Braunfels, Texas, United States, 78130
Research Site
El Paso, Texas, United States, 79902
Research Site
Houston, Texas, United States, 77054
United States, Vermont
Research Site
South Burlington, Vermont, United States, 05403
United States, Wisconsin
Research Site
Greenfield, Wisconsin, United States, 53228
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 3J5
Research Site
Kelowna, British Columbia, Canada, V1Y 9L8
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8N 1Y2
Research Site
Toronto, Ontario, Canada, M4P 1P2
Research Site
London, Ontario, Canada, N6A 1V2
Research Site
Mississauga, Ontario, Canada, L4W 1N2
Research Site
Oshawa, Ontario, Canada, L1H 1B9
Research Center
London, Ontario, Canada, N5X 4E7
Canada, Quebec
Research Site
Longueuil, Quebec, Canada, J4N 1E1
Research Site
Trois Rivieres, Quebec, Canada, G8T 7A1
Research Site
Saint Foy, Quebec, Canada, G1V 4M6
Research Site
Montreal, Quebec, Canada, H2L 2W5
Sponsors and Collaborators
SkyePharma AG
  More Information

No publications provided

Study ID Numbers: SKY2028-3-002
Study First Received: October 27, 2006
Last Updated: May 27, 2008
ClinicalTrials.gov Identifier: NCT00394199     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by SkyePharma AG:
Asthma
Fluticasone Propionate
formoterol fumarate
Pressurized metered dose inhaler
Hydrofluoroalkane
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 November 30, 2009