- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00393991
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
June 8, 2011 updated by: SkyePharma AG
A Randomized, Double-blind, Placebo-controlled, Parallel, 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 Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma
The purpose of this study is 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, and with placebo in adult and adolescent patients with mild to moderate asthma.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
475
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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St. John's, Canada, A1B 4S8
- Research Site
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Ontario
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Ajax, Ontario, Canada, L1S 2J5
- Research Site
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Mississauga, Ontario, Canada, L5B 1N1
- Research Site
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Ottawa, Ontario, Canada, K1Y 4G2
- Research Site
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Point Edward, Ontario, Canada, N7V 1X4
- Research Site
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Sudbury, Ontario, Canada, P3A 1Y8
- Research Site
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Sudbury, Ontario, Canada, P3A1Y8
- Research Site
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Toronto, Ontario, Canada, M5S 2A5
- Research Site
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Toronto, Ontario, Canada, M6H 3M2
- Research Site
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Quebec
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St. Romuald, Quebec, Canada, G6W 5M6
- Research Site
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Alabama
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Pell City, Alabama, United States, 35128
- Research Site
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Arizona
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Scottsdale, Arizona, United States, 85251
- Research Site
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California
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Cypress, California, United States, 90630
- Research Site
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Encinitas, California, United States, 92024
- Research Site
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Fountain Valley, California, United States, 92708
- Research Site
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Los Angeles, California, United States, 90048
- Research Center
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Mission Hills, California, United States, 91345
- Research Site
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Colorado
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Centennial, Colorado, United States, 80112
- Research Site
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Colorado Springs, Colorado, United States, 80907
- Research Site
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Englewood, Colorado, United States, 80112
- Research Site
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Connecticut
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Waterbury, Connecticut, United States, 06708
- Research Site
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Florida
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Aventura, Florida, United States, 33180
- Research Site
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Gainesville, Florida, United States, 32610
- Research Site
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Largo, Florida, United States, 33770
- Research Center
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Miami, Florida, United States, 33176
- Research Site
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Ocala, Florida, United States, 34471
- Research Site
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Tallahassee, Florida, United States, 32308
- Research Site
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Georgia
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Conyers, Georgia, United States, 30012
- Research Site
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Lawrenceville, Georgia, United States, 32308
- Research Site
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Illinois
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Round Lake Beach, Illinois, United States, 60073
- Research Site
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Indiana
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Indianapolis, Indiana, United States, 46208
- Research Site
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Maryland
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Bethesda, Maryland, United States, 20814
- Research Site
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Massachusetts
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Brockton, Massachusetts, United States, 02301
- Research Site
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New Jersey
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Cherry Hill, New Jersey, United States, 08003
- Research Site
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Forked River, New Jersey, United States, 08732
- Research Site
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North Carolina
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Asheville, North Carolina, United States, 28801
- Research Site
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Elizabeth City, North Carolina, United States, 27909
- Research Site
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Elizabeth City, North Carolina, United States, 27909
- Research Center
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Ohio
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Columbus, Ohio, United States, 43235
- Research Site
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Toledo, Ohio, United States, 43617
- Research Site
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Oklahoma
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Okalahoma City, Oklahoma, United States, 73139
- Research Site
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Oklahoma, Oklahoma, United States, 73104
- Research Site
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Oklahoma City, Oklahoma, United States, 73112
- Research Site
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Oregon
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Eugene, Oregon, United States, 97401
- Research Site
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Lake Oswego, Oregon, United States, 97035
- Research Site
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Medford, Oregon, United States, 97504
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19115
- Research Site
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Pittsburgh, Pennsylvania, United States, 15241
- Research Site
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Scranton, Pennsylvania, United States, 18509
- Research Site
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Texas
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Austin, Texas, United States, 78750
- Research Site
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Dallas, Texas, United States, 75246
- Research Site
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El Paso, Texas, United States, 79925
- Research Site
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Houston, Texas, United States, 77024
- Research Site
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McKinney, Texas, United States, 75069
- Research Site
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Round Rock, Texas, United States, 78681
- Research Site
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San Antonio, Texas, United States, 78229
- Research Site
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Washington
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Bellingham, Washington, United States, 98225
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 steroid-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:
- Life-threatening asthma within past year or during Run-In Period.
- History of systemic corticosteroid medication within 3 months before 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 4
Placebo
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Placebo is a HFA pMDI that delivers placebo aerosol.
Patients will take 2 actuations BID for 12 weeks.
Other Names:
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Experimental: 1
FlutiForm 100/10 μg
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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 Names:
|
Active Comparator: 2
Fluticasone 100 μg
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Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation.
Patients will take 2 actuations BID for 12 weeks.
Other Names:
|
Active Comparator: 3
Formoterol 10 μg
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Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation.
Patients will take 2 actuations BID for 12 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy
Time Frame: Week 0 and 12 visits
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Week 0 and 12 visits
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR).
Time Frame: Whole duration of study
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Whole duration of study
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Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).
Time Frame: Whole duration of study
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Whole duration of study
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Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs.
Time Frame: Whole duration of study
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Whole duration of study
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Serial 12-hour FEV-1 area under the curve (AUC).
Time Frame: Week 0, 2 and 12 visits
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Week 0, 2 and 12 visits
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
October 27, 2006
First Submitted That Met QC Criteria
October 30, 2006
First Posted (Estimate)
October 31, 2006
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Fluticasone
- Xhance
- Formoterol Fumarate
Other Study ID Numbers
- SKY2028-3-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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