New Combination Inhaler (Flutiform HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma

Condition(s) targeted: Asthma

Intervention: Fluticasone propionate/Formoterol fumarate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: SkyePharma AG

The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug Flutiform with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Stratified, Multi-Center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm) 100/10 µg or 250/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Placebo or Fluticasone (250 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Moderate to Severe Asthma

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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:

Other pulmonary function tests including forced vial 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).

Serial FEV-1 area under the curve (AUC).

Safety variable including adverse events, ECGs clinical laboratory tests and vital signs.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Ages eligible for study: 12 years and above; genders eligible for study: both; prior steriod use: steriod-requiring

Inclusion Criteria:

- History of asthma for at least 12 months.

- Documented use of inhaled corticosteriod for at least 4 weeks prior to Screening Visit

Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.

- Documented reversibility of 15% within 12 months of Screening visit 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 corticosteriod 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.

Research Center, Ponce 00733, Puerto Rico

Research Center, Pell City, Alabama 35128, United States

Research Site, Tucson, Arizona 85712, United States

Research Site, Phoenix, Arizona 85050, United States

Research Site, Glendale, Arizona 85306, United States

Research Center, Phoenix, Arizona 85050, United States

Research Site, Jonesboro, Arkansas 72401, United States

Research Site, Little Rock, Arkansas 72205, United States

Research Site, Fresno, California 93720, United States

Research Site, Los Angeles, California 90025, United States

Research Site, Monterey Park, California 91754, United States

Research Site, San Jose, California 95128, United States

Research Site, San Diego, California 92120, United States

Research Site, Long Beach, California 90806, United States

Research Site, Burbank, California 91505, United States

Research Site, San Diego, California 92123, United States

Research Site, Mission Viejo, California 92691, United States

Research Site, Los Angeles, California 90048, United States

Research Site, Palmdale, California 93551, United States

Research Site, Sacramento, California 95819, United States

Research Center, Los Angeles, California 90048, United States

Research Site, Hialeah, Florida 33013, United States

Research Site, Pensacola, Florida 32503, United States

Research Site, Tampa, Florida 33613, United States

Research Site, Ormond Beach, Florida 32174, United States

Research Center, Gainesville, Florida 32605, United States

Research Center, Panama City, Florida 32405, United States

Research Site, Savannah, Georgia 31406, United States

Research Center, Congers, Georgia 30012, United States

Research Site, Round Lake Beach, Illinois 60073, United States

Research Site, Louisville, Kentucky 40215, United States

Research Site, Baltimore, Maryland 21236, United States

Research Site, Taunton, Massachusetts 02780, United States

Research Site, N. Dartmouth, Massachusetts 02747, United States

Research Site, Plymouth, Minnesota 55441, United States

Research Site, Minneapolis, Minnesota 55402, United States

Research Center, Minneapolis, Minnesota 55402, United States

Research Site, St. Louis, Missouri 63141, United States

Research Site, Bozeman, Montana 59718, United States

Research Site, Omaha, Nebraska 68130, United States

Research Site, Las Vegas, Nevada 89123, United States

Research Site, Brick, New Jersey 08724, United States

Research Site, Mt. Laurel, New Jersey 08054, United States

Research Site, Skillman, New Jersey 08558, United States

Research Site, Tinton Falls, New Jersey 07001, United States

Research Site, Rockville Centre, New York 11570, United States

Research Site, Oklahoma City, Oklahoma 73139, United States

Research Site, Ashland, Oregon 97520, United States

Research Site, Medford, Oregon 97504, United States

Research Center, Portland, Oregon 97213, United States

Research Center, Upland, Pennsylvania 19013, United States

Research Site, Lincoln, Rhode Island 02865, United States

Research Site, Greenville, South Carolina 29607, United States

Research Center, Anderson, South Carolina 29621, United States

Research Site, San Antonio, Texas 78229, United States

Research Site, Dallas, Texas 75231, United States

Research Site, Austin, Texas 78750, United States

Research Site, El Paso, Texas 79902, United States

Research Site, San Antonio, Texas 72205, United States

Research Center, Forth Worth, Texas 76104, United States

Research Site, Richmond, Virginia 23225, United States

Research Site, Tacoma, Washington 98405, United States

Research Site, Milwaukee, Wisconsin 53209, United States

Starting date: June 2006
Ending date: January 2008
Last updated: January 7, 2008