Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma - Full Text View

Sponsor:	SkyePharma AG
Information provided by:	SkyePharma AG
ClinicalTrials.gov Identifier:	NCT00393991

Purpose

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.

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, 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

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 in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy

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 including adverse events, ECGs, clinical laboratory tests and vital signs.
Serial FEV-1 area under the curve (AUC).

Estimated Enrollment:	440
Study Start Date:	July 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 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 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 nebullized 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393991

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Locations

United States, Alabama
Research Site
Pell City, Alabama, United States, 35128
United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85251
United States, California
Research Site
Mission Hills, California, United States, 91345
Research Center
Los Angeles, California, United States, 90048
Research Site
Cypress, California, United States, 90630
Research Site
Fountain Valley, California, United States, 92708
Research Site
Encinitas, California, United States, 92024
United States, Colorado
Research Site
Englewood, Colorado, United States, 80112
Research Site
Colorado Springs, Colorado, United States, 80907
Research Site
Centennial, Colorado, United States, 80112
United States, Connecticut
Research Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Research Site
Tallahassee, Florida, United States, 32308
Research Site
Ocala, Florida, United States, 34471
Research Site
Aventura, Florida, United States, 33180
Research Site
Gainesville, Florida, United States, 32610
Research Site
Miami, Florida, United States, 33176
Research Center
Largo, Florida, United States, 33770
United States, Georgia
Research Site
Lawrenceville, Georgia, United States, 32308
Research Site
Conyers, Georgia, United States, 30012
United States, Illinois
Research Site
Round Lake Beach, Illinois, United States, 60073
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46208
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Research Site
Brockton, Massachusetts, United States, 02301
United States, New Jersey
Research Site
Forked River, New Jersey, United States, 08732
Research Site
Cherry Hill, New Jersey, United States, 08003
United States, North Carolina
Research Center
Elizabeth City, North Carolina, United States, 27909
Research Site
Elizabeth City, North Carolina, United States, 27909
Research Site
Asheville, North Carolina, United States, 28801
United States, Ohio
Research Site
Columbus, Ohio, United States, 43235
Research Site
Toledo, Ohio, United States, 43617
United States, Oklahoma
Research Site
Oklahoma, Oklahoma, United States, 73104
Research Site
Oklahoma City, Oklahoma, United States, 73112
Research Site
Okalahoma City, Oklahoma, United States, 73139
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
Research Site
Eugene, Oregon, United States, 97401
Research Site
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19115
Research Site
Pittsburgh, Pennsylvania, United States, 15241
Research Site
Scranton, Pennsylvania, United States, 18509
United States, Texas
Research Site
Houston, Texas, United States, 77024
Research Site
Round Rock, Texas, United States, 78681
Research Site
El Paso, Texas, United States, 79925
Research Site
San Antonio, Texas, United States, 78229
Research Site
McKinney, Texas, United States, 75069
Research Site
Dallas, Texas, United States, 75246
Research Site
Austin, Texas, United States, 78750
United States, Washington
Research Site
Bellingham, Washington, United States, 98225
Canada
Research Site
St. John's, Canada, A1B 4S8
Canada, Ontario
Research Site
Sudbury, Ontario, Canada, P3A1Y8
Research Site
Mississauga, Ontario, Canada, L5B 1N1
Research Site
Toronto, Ontario, Canada, M6H 3M2
Research Site
Sudbury, Ontario, Canada, P3A 1Y8
Research Site
Ottawa, Ontario, Canada, K1Y 4G2
Research Site
Ajax, Ontario, Canada, L1S 2J5
Research Site
Toronto, Ontario, Canada, M5S 2A5
Research Site
Point Edward, Ontario, Canada, N7V 1X4
Canada, Quebec
Research Site
St. Romuald, Quebec, Canada, G6W 5M6

Sponsors and Collaborators

SkyePharma AG

More Information

No publications provided

Study ID Numbers:	SKY2028-3-001
Study First Received:	October 27, 2006
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00393991 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 27, 2009