Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
A Randomized, Double-blind, Active-controlled, Parallel Group, 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 Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & Adult Patients With Mild to Moderate Asthma
1 other identifier
interventional
357
2 countries
41
Brief Summary
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, in adult and adolescent patients with mild to moderate 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
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedJune 23, 2011
June 1, 2011
1.7 years
October 27, 2006
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12
Week 0 and 12
Secondary Outcomes (3)
Other pulmonary function tests including forced vital 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
Safety variables include adverse events, ECGs, clinical laboratory tests and vital signs.
Whole duration of study
Study Arms (3)
1
EXPERIMENTALFlutiForm 100/10ug
2
EXPERIMENTALFluticasone 100
3
ACTIVE COMPARATORFormoterol 10
Interventions
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 100 is a HFA pMDI that delivers 50ug 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
- For steriod-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 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:
- Patients will not be eligible for the study if they meet any of the following criteria:
- Life-threatening asthma within the past year or during the Run-In Period.
- History of systemic corticosteroid medication within 3 months before the 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 (41)
Research Site
Birmingham, Alabama, 35242, United States
Research Site
Mission Viejo, California, 92691, United States
Research Site
Orange, California, 92868, United States
Research Site
San Jose, California, 95117, United States
Research Site
Vista, California, 92083, United States
Research Site
Denver, Colorado, 80230, United States
Research Site
Lilburn, Georgia, 30047, United States
Research Site
Savannah, Georgia, 31406, United States
Research Site
Park City, Kansas, 67219, United States
Research Site
Bethesda, Maryland, 20814, United States
Research Site
North Dartmouth, Massachusetts, 02747, United States
Research Center
Stevensville, Michigan, 49127, United States
Research Site
Elizabeth, New Jersey, 07202, United States
Research Center
Rochester, New York, 14618, United States
Research Site
Asheville, North Carolina, 28801, United States
Research Site
Raleigh, North Carolina, 27607, United States
Research Site
Cincinnati, Ohio, 45242, United States
Research Site
Sylvania, Ohio, 43560, United States
Research Site
Easton, Pennsylvania, 18045, United States
Research Site
Lincoln, Rhode Island, 02906, United States
Research Site
Greenville, South Carolina, 29605, United States
Research Site
Chattanooga, Tennessee, 37421, United States
Research Site
El Paso, Texas, 79902, United States
Research Site
Houston, Texas, 77054, United States
Research Site
Katy, Texas, 77450, United States
Research Site
New Braunfels, Texas, 78130, United States
Research Site
Waco, Texas, 76712, United States
Research Site
South Burlington, Vermont, 05403, United States
Research Site
Greenfield, Wisconsin, 53228, United States
Research Site
Kelowna, British Columbia, V1Y 9L8, Canada
Research Site
Vancouver, British Columbia, V5Z 3J5, Canada
Research Site
Hamilton, Ontario, L8N 1Y2, Canada
Research Center
London, Ontario, N5X 4E7, Canada
Research Site
London, Ontario, N6A 1V2, Canada
Research Site
Mississauga, Ontario, L4W 1N2, Canada
Research Site
Oshawa, Ontario, L1H 1B9, Canada
Research Site
Toronto, Ontario, M4P 1P2, Canada
Research Site
Longueuil, Quebec, J4N 1E1, Canada
Research Site
Montreal, Quebec, H2L 2W5, Canada
Research Site
Saint Foy, Quebec, G1V 4M6, Canada
Research Site
Trois-Rivières, Quebec, G8T 7A1, Canada
Related Publications (1)
Pearlman DS, LaForce CF, Kaiser K. Fluticasone/Formoterol combination therapy compared with monotherapy in adolescent and adult patients with mild to moderate asthma. Clin Ther. 2013 Jul;35(7):950-66. doi: 10.1016/j.clinthera.2013.05.012.
PMID: 23870606DERIVED
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
February 1, 2008
Study Completion
February 1, 2008
Last Updated
June 23, 2011
Record last verified: 2011-06