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
1 other identifier
interventional
557
2 countries
63
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Jun 2006
Typical duration for phase_3 asthma
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 27, 2006
CompletedFirst Posted
Study publicly available on registry
October 31, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedJune 23, 2011
June 1, 2011
1.8 years
October 27, 2006
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Other pulmonary function tests including forced vial capacity (FVC) and peak expiratory flow rate (PEFR).
Whole duration of study
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
Safety variables including adverse events, ECGs clinical laboratory tests and vital signs.
Whole duration of study
Study Arms (5)
1
EXPERIMENTALFlutiForm 250/10
2
ACTIVE COMPARATORFlutiForm 100/10
3
ACTIVE COMPARATORFluticasone 250
4
ACTIVE COMPARATORFormoterol 10
5
PLACEBO COMPARATORPlacebo
Interventions
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.
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
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.
Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SkyePharma AGlead
Study Sites (63)
Research Center
Pell City, Alabama, 35128, United States
Research Site
Glendale, Arizona, 85306, United States
Research Center
Phoenix, Arizona, 85050, United States
Research Site
Phoenix, Arizona, 85050, United States
Research Site
Tucson, Arizona, 85712, United States
Research Site
Jonesboro, Arkansas, 72401, United States
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Burbank, California, 91505, United States
Research Site
Fresno, California, 93720, United States
Research Site
Long Beach, California, 90806, United States
Research Site
Los Angeles, California, 90025, United States
Research Center
Los Angeles, California, 90048, United States
Research Site
Los Angeles, California, 90048, United States
Research Site
Mission Viejo, California, 92691, United States
Research Site
Monterey Park, California, 91754, United States
Research Site
Palmdale, California, 93551, United States
Research Site
Sacramento, California, 95819, United States
Research Site
San Diego, California, 92120, United States
Research Site
San Diego, California, 92123, United States
Research Site
San Jose, California, 95128, United States
Research Center
Gainesville, Florida, 32605, United States
Research Site
Hialeah, Florida, 33013, United States
Research Site
Ormond Beach, Florida, 32174, United States
Research Center
Panama City, Florida, 32405, United States
Research Site
Pensacola, Florida, 32503, United States
Research Site
Tampa, Florida, 33613, United States
Research Center
Congers, Georgia, 30012, United States
Research Site
Savannah, Georgia, 31406, 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
North Dartmouth, Massachusetts, 02747, United States
Research Site
Taunton, Massachusetts, 02780, United States
Research Center
Minneapolis, Minnesota, 55402, United States
Research Site
Minneapolis, Minnesota, 55402, United States
Research Site
Plymouth, Minnesota, 55441, 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
Mount 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 Center
Anderson, South Carolina, 29621, United States
Research Site
Greenville, South Carolina, 29607, United States
Research Site
Austin, Texas, 78750, United States
Research Site
Dallas, Texas, 75231, United States
Research Site
El Paso, Texas, 79902, United States
Research Center
Fort Worth, Texas, 76104, United States
Research Site
San Antonio, Texas, 72205, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Richmond, Virginia, 23225, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Milwaukee, Wisconsin, 53209, United States
Research Center
Ponce, 00733, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 27, 2006
First Posted
October 31, 2006
Study Start
June 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
June 23, 2011
Record last verified: 2011-06