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Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00394199
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
SkyePharma AG

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Fluticasone propionate/Formoterol Fumarate 100/10 Drug: Fluticasone propionate 100 Drug: Formoterol fumarate 10 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008


Arm Intervention/treatment
Experimental: 1
FlutiForm 100/10ug
Drug: Fluticasone propionate/Formoterol Fumarate 100/10
FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: Flutiform 100/10

Experimental: 2
Fluticasone 100
Drug: Fluticasone propionate 100
Fluticasone 100 is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: Fluticasone 100

Active Comparator: 3
Formoterol 10
Drug: Formoterol fumarate 10
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: SKP Formoterol 10




Primary Outcome Measures :
  1. Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12 [ Time Frame: Week 0 and 12 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Ages eligible for study: 12 years and above
  • Genders eligible for study: both
  • Prior steroid 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 nebulized 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394199


Locations
Hide Hide 41 study locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35242
United States, California
Research Site
Mission Viejo, California, United States, 92691
Research Site
Orange, California, United States, 92868
Research Site
San Jose, California, United States, 95117
Research Site
Vista, California, United States, 92083
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
El Paso, Texas, United States, 79902
Research Site
Houston, Texas, United States, 77054
Research Site
Katy, Texas, United States, 77450
Research Site
New Braunfels, Texas, United States, 78130
Research Site
Waco, Texas, United States, 76712
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
Kelowna, British Columbia, Canada, V1Y 9L8
Research Site
Vancouver, British Columbia, Canada, V5Z 3J5
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8N 1Y2
Research Center
London, Ontario, Canada, N5X 4E7
Research Site
London, Ontario, Canada, N6A 1V2
Research Site
Mississauga, Ontario, Canada, L4W 1N2
Research Site
Oshawa, Ontario, Canada, L1H 1B9
Research Site
Toronto, Ontario, Canada, M4P 1P2
Canada, Quebec
Research Site
Longueuil, Quebec, Canada, J4N 1E1
Research Site
Montreal, Quebec, Canada, H2L 2W5
Research Site
Saint Foy, Quebec, Canada, G1V 4M6
Research Site
Trois Rivieres, Quebec, Canada, G8T 7A1
Sponsors and Collaborators
SkyePharma AG

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SkyePharma AG
ClinicalTrials.gov Identifier: NCT00394199    
Other Study ID Numbers: SKY2028-3-002
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Keywords provided by SkyePharma AG:
Asthma
Fluticasone Propionate
formoterol fumarate
Pressurized metered dose inhaler
Hydrofluoroalkane
Mild to Moderate Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action