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

Condition(s) targeted: Asthma

Intervention: Fluticasone propionate/Formoterol fumarate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: SkyePharma AG

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.

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

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 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).

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 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

Research Site, St. John's A1B 4S8, Canada

Research Site, Pell City, Alabama 35128, United States

Research Site, Scottsdale, Arizona 85251, United States

Research Site, Mission Hills, California 91345, United States

Research Site, Encinitas, California 92024, United States

Research Site, Cypress, California 90630, United States

Research Site, Fountain Valley, California 92708, United States

Research Center, Los Angeles, California 90048, United States

Research Site, Englewood, Colorado 80112, United States

Research Site, Colorado Springs, Colorado 80907, United States

Research Site, Centennial, Colorado 80112, United States

Research Site, Waterbury, Connecticut 06708, United States

Research Site, Aventura, Florida 33180, United States

Research Site, Ocala, Florida 34471, United States

Research Site, Tallahassee, Florida 32308, United States

Research Site, Gainesville, Florida 32610, United States

Research Site, Miami, Florida 33176, United States

Research Center, Largo, Florida 33770, United States

Research Site, Lawrenceville, Georgia 32308, United States

Research Site, Conyers, Georgia 30012, United States

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

Research Site, Indianapolis, Indiana 46208, United States

Research Site, Bethesda, Maryland 20814, United States

Research Site, Brockton, Massachusetts 02301, United States

Research Site, Forked River, New Jersey 08732, United States

Research Site, Cherry Hill, New Jersey 08003, United States

Research Site, Asheville, North Carolina 28801, United States

Research Site, Elizabeth City, North Carolina 27909, United States

Research Center, Elizabeth City, North Carolina 27909, United States

Research Site, Columbus, Ohio 43235, United States

Research Site, Toledo, Ohio 43617, United States

Research Site, Oklahoma, Oklahoma 73104, United States

Research Site, Oklahoma City, Oklahoma 73112, United States

Research Site, Okalahoma City, Oklahoma 73139, United States

Research Site, Sudbury, Ontario P3A1Y8, Canada

Research Site, Mississauga, Ontario L5B 1N1, Canada

Research Site, Toronto, Ontario M6H 3M2, Canada

Research Site, Sudbury, Ontario P3A 1Y8, Canada

Research Site, Ottawa, Ontario K1Y 4G2, Canada

Research Site, Ajax, Ontario L1S 2J5, Canada

Research Site, Toronto, Ontario M5S 2A5, Canada

Research Site, Point Edward, Ontario N7V 1X4, Canada

Research Site, Medford, Oregon 97504, United States

Research Site, Eugene, Oregon 97401, United States

Research Site, Lake Oswego, Oregon 97035, United States

Research Site, Philadelphia, Pennsylvania 19115, United States

Research Site, Pittsburgh, Pennsylvania 15241, United States

Research Site, Scranton, Pennsylvania 18509, United States

Research Site, St. Romuald, Quebec G6W 5M6, Canada

Research Site, Houston, Texas 77024, United States

Research Site, San Antonio, Texas 78229, United States

Research Site, El Paso, Texas 79925, United States

Research Site, Round Rock, Texas 78681, United States

Research Site, McKinney, Texas 75069, United States

Research Site, Dallas, Texas 75246, United States

Research Site, Austin, Texas 78750, United States

Research Site, Bellingham, Washington 98225, United States

Starting date: July 2006
Ending date: April 2008
Last updated: May 27, 2008