Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
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
1 other identifier
interventional
475
2 countries
57
Brief Summary
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.
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 Jul 2006
57 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
July 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 (1)
Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy
Week 0 and 12 visits
Secondary Outcomes (4)
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 including adverse events, ECGs, clinical laboratory tests and vital signs.
Whole duration of study
Serial 12-hour FEV-1 area under the curve (AUC).
Week 0, 2 and 12 visits
Study Arms (4)
1
EXPERIMENTALFlutiForm 100/10 μg
2
ACTIVE COMPARATORFluticasone 100 μg
3
ACTIVE COMPARATORFormoterol 10 μg
4
PLACEBO COMPARATORPlacebo
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 100ug 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.
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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 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 (57)
Research Site
Pell City, Alabama, 35128, United States
Research Site
Scottsdale, Arizona, 85251, United States
Research Site
Cypress, California, 90630, United States
Research Site
Encinitas, California, 92024, United States
Research Site
Fountain Valley, California, 92708, United States
Research Center
Los Angeles, California, 90048, United States
Research Site
Mission Hills, California, 91345, United States
Research Site
Centennial, Colorado, 80112, United States
Research Site
Colorado Springs, Colorado, 80907, United States
Research Site
Englewood, Colorado, 80112, United States
Research Site
Waterbury, Connecticut, 06708, United States
Research Site
Aventura, Florida, 33180, United States
Research Site
Gainesville, Florida, 32610, United States
Research Center
Largo, Florida, 33770, United States
Research Site
Miami, Florida, 33176, United States
Research Site
Ocala, Florida, 34471, United States
Research Site
Tallahassee, Florida, 32308, United States
Research Site
Conyers, Georgia, 30012, United States
Research Site
Lawrenceville, Georgia, 32308, 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
Cherry Hill, New Jersey, 08003, United States
Research Site
Forked River, New Jersey, 08732, United States
Research Site
Asheville, North Carolina, 28801, United States
Research Center
Elizabeth City, North Carolina, 27909, United States
Research Site
Elizabeth City, North Carolina, 27909, United States
Research Site
Columbus, Ohio, 43235, United States
Research Site
Toledo, Ohio, 43617, United States
Research Site
Okalahoma City, Oklahoma, 73139, United States
Research Site
Oklahoma City, Oklahoma, 73104, United States
Research Site
Oklahoma City, Oklahoma, 73112, United States
Research Site
Eugene, Oregon, 97401, United States
Research Site
Lake Oswego, Oregon, 97035, United States
Research Site
Medford, Oregon, 97504, 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
Austin, Texas, 78750, United States
Research Site
Dallas, Texas, 75246, United States
Research Site
El Paso, Texas, 79925, United States
Research Site
Houston, Texas, 77024, United States
Research Site
McKinney, Texas, 75069, United States
Research Site
Round Rock, Texas, 78681, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Bellingham, Washington, 98225, United States
Research Site
Ajax, Ontario, L1S 2J5, Canada
Research Site
Greater Sudbury, Ontario, P3A 1Y8, Canada
Research Site
Greater Sudbury, Ontario, P3A1Y8, Canada
Research Site
Mississauga, Ontario, L5B 1N1, Canada
Research Site
Ottawa, Ontario, K1Y 4G2, Canada
Research Site
Point Edward, Ontario, N7V 1X4, Canada
Research Site
Toronto, Ontario, M5S 2A5, Canada
Research Site
Toronto, Ontario, M6H 3M2, Canada
Research Site
Saint Romuald, Quebec, G6W 5M6, Canada
Research Site
St. John's, A1B 4S8, Canada
Related Publications (1)
Nathan RA, D'Urzo A, Blazhko V, Kaiser K. Safety and efficacy of fluticasone/formoterol combination therapy in adolescent and adult patients with mild-to-moderate asthma: a randomised controlled trial. BMC Pulm Med. 2012 Oct 18;12:67. doi: 10.1186/1471-2466-12-67.
PMID: 23078148DERIVED
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
July 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
June 23, 2011
Record last verified: 2011-06