Clinical trial NCT00393952: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Fluticasone Propionate
Formoterol Fumarate
Pressurized metered dose inhaler
Hydrofluoroalkane
Moderate-Severe Asthma
Lead sponsor: SkyePharma AG
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 557
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12.
timeFrame: Week 0 and 12 visits
measure: Discontinuation due to lack of efficacy.
timeFrame: Whole duration of study
Secondary outcomes:
measure: Other pulmonary function tests including forced vial capacity (FVC) and peak expiratory flow rate (PEFR).
timeFrame: Whole duration of study
measure: Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).
timeFrame: Whole duration of study
measure: Serial 12-hour FEV-1 area under the curve (AUC).
timeFrame: Week 0, 2 and 12 visits
measure: Safety variables including adverse events, ECGs clinical laboratory tests and vital signs.
timeFrame: Whole duration of study
Other outcomes:
Locations:
city: Pell City
country: United States
facility: Research Center
state: Alabama
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Center
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Jonesboro
country: United States
facility: Research Site
state: Arkansas
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Burbank
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Monterey Park
country: United States
facility: Research Site
state: California
city: Palmdale
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Jose
country: United States
facility: Research Site
state: California
city: Gainesville
country: United States
facility: Research Center
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Ormond Beach
country: United States
facility: Research Site
state: Florida
city: Panama City
country: United States
facility: Research Center
state: Florida
city: Pensacola
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Congers
country: United States
facility: Research Center
state: Georgia
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Round Lake Beach
country: United States
facility: Research Site
state: Illinois
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: N. Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Taunton
country: United States
facility: Research Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Research Center
state: Minnesota
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Plymouth
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Bozeman
country: United States
facility: Research Site
state: Montana
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Brick
country: United States
facility: Research Site
state: New Jersey
city: Mt. Laurel
country: United States
facility: Research Site
state: New Jersey
city: Skillman
country: United States
facility: Research Site
state: New Jersey
city: Tinton Falls
country: United States
facility: Research Site
state: New Jersey
city: Rockville Centre
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Ashland
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Center
state: Oregon
city: Upland
country: United States
facility: Research Center
state: Pennsylvania
city: Lincoln
country: United States
facility: Research Site
state: Rhode Island
city: Anderson
country: United States
facility: Research Center
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Fort Worth
country: United States
facility: Research Center
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Ponce
country: Puerto Rico
facility: Research Center
Study officials:
References: