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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Formoterol fumarate 10; Drug: Placebo; Drug: Fluticasone propionate/Formoterol fumarate 250/10; Drug: Fluticasone propionate/Formoterol fumarate 100/10; Drug: Fluticasone propionate 250

• Study Type: Interventional
• Enrollment (Actual): 557
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00733
    • Research Center
• United States
  • Alabama
    • Pell City, Alabama, United States, 35128
      • Research Center
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Research Site
    • Phoenix, Arizona, United States, 85050
      • Research Center
    • Phoenix, Arizona, United States, 85050
      • Research Site
    • Tucson, Arizona, United States, 85712
      • Research Site
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Research Site
    • Little Rock, Arkansas, United States, 72205
      • Research Site
  • California
    • Burbank, California, United States, 91505
      • Research Site
    • Fresno, California, United States, 93720
      • Research Site
    • Long Beach, California, United States, 90806
      • Research Site
    • Los Angeles, California, United States, 90025
      • Research Site
    • Los Angeles, California, United States, 90048
      • Research Site
    • Los Angeles, California, United States, 90048
      • Research Center
    • Mission Viejo, California, United States, 92691
      • Research Site
    • Monterey Park, California, United States, 91754
      • Research Site
    • Palmdale, California, United States, 93551
      • Research Site
    • Sacramento, California, United States, 95819
      • Research Site
    • San Diego, California, United States, 92120
      • Research Site
    • San Diego, California, United States, 92123
      • Research Site
    • San Jose, California, United States, 95128
      • Research Site
  • Florida
    • Gainesville, Florida, United States, 32605
      • Research Center
    • Hialeah, Florida, United States, 33013
      • Research Site
    • Ormond Beach, Florida, United States, 32174
      • Research Site
    • Panama City, Florida, United States, 32405
      • Research Center
    • Pensacola, Florida, United States, 32503
      • Research Site
    • Tampa, Florida, United States, 33613
      • Research Site
  • Georgia
    • Congers, Georgia, United States, 30012
      • Research Center
    • Savannah, Georgia, United States, 31406
      • Research Site
  • Illinois
    • Round Lake Beach, Illinois, United States, 60073
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • Research Site
  • Massachusetts
    • N. Dartmouth, Massachusetts, United States, 02747
      • Research Site
    • Taunton, Massachusetts, United States, 02780
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Research Site
    • Minneapolis, Minnesota, United States, 55402
      • Research Center
    • Plymouth, Minnesota, United States, 55441
      • Research Site
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • Research Site
  • Montana
    • Bozeman, Montana, United States, 59718
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Research Site
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • Research Site
    • Mt. Laurel, New Jersey, United States, 08054
      • Research Site
    • Skillman, New Jersey, United States, 08558
      • Research Site
    • Tinton Falls, New Jersey, United States, 07001
      • Research Site
  • New York
    • Rockville Centre, New York, United States, 11570
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73139
      • Research Site
  • Oregon
    • Ashland, Oregon, United States, 97520
      • Research Site
    • Medford, Oregon, United States, 97504
      • Research Site
    • Portland, Oregon, United States, 97213
      • Research Center
  • Pennsylvania
    • Upland, Pennsylvania, United States, 19013
      • Research Center
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Research Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Research Center
    • Greenville, South Carolina, United States, 29607
      • Research Site
  • Texas
    • Austin, Texas, United States, 78750
      • Research Site
    • Dallas, Texas, United States, 75231
      • Research Site
    • El Paso, Texas, United States, 79902
      • Research Site
    • Fort Worth, Texas, United States, 76104
      • Research Center
    • San Antonio, Texas, United States, 78229
      • Research Site
    • San Antonio, Texas, United States, 72205
      • Research Site
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Research Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Research Site

Participation Criteria

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

Inclusion Criteria:

• History of asthma for at least 12 months.
• Documented use of inhaled corticosteroid 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 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 5; Placebo	Drug: Placebo; Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.; Other Names: SKP Placebo
Experimental: 1; FlutiForm 250/10	Drug: Fluticasone propionate/Formoterol fumarate 250/10; FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.; Other Names: FlutiForm 250/10
Active Comparator: 2; FlutiForm 100/10	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 Names: FlutiForm 100/10
Active Comparator: 3; Fluticasone 250	Drug: Fluticasone propionate 250; Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.; Other Names: Fluticasone 250
Active Comparator: 4; 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 Names: SKP Formoterol 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12.	Week 0 and 12 visits
Discontinuation due to lack of efficacy.	Whole duration of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).	Whole duration of study
Serial 12-hour FEV-1 area under the curve (AUC).	Week 0, 2 and 12 visits
Other pulmonary function tests including forced vial capacity (FVC) and peak expiratory flow rate (PEFR).	Whole duration of study
Safety variables including adverse events, ECGs clinical laboratory tests and vital signs.	Whole duration of study

Collaborators and Investigators

• Sponsor: SkyePharma AG

Study record dates

Study Major Dates

• Study Start: June 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: Asthma; Formoterol Fumarate; Fluticasone Propionate; Pressurized metered dose inhaler; Hydrofluoroalkane; Moderate-Severe Asthma
• 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: SKY2028-3-004