Clinical trial NCT00393991: Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Fluticasone Propionate
Formoterol Fumarate
Pressurized metered dose inhaler
Hydrofluoroalkane
Mild to Moderate Asthma
Lead sponsor: SkyePharma AG
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 475
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 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.


Eligibility criteria: Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring or steroid-free.

Inclusion Criteria:

* 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.

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) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy
timeFrame: Week 0 and 12 visits
Secondary outcomes:
measure: Other pulmonary function tests including forced vital 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: Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs.
timeFrame: Whole duration of study
measure: Serial 12-hour FEV-1 area under the curve (AUC).
timeFrame: Week 0, 2 and 12 visits
Other outcomes:
Locations:
city: Pell City
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Cypress
country: United States
facility: Research Site
state: California
city: Encinitas
country: United States
facility: Research Site
state: California
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Mission Hills
country: United States
facility: Research Site
state: California
city: Centennial
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Largo
country: United States
facility: Research Center
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Tallahassee
country: United States
facility: Research Site
state: Florida
city: Conyers
country: United States
facility: Research Site
state: Georgia
city: Lawrenceville
country: United States
facility: Research Site
state: Georgia
city: Round Lake Beach
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Brockton
country: United States
facility: Research Site
state: Massachusetts
city: Cherry Hill
country: United States
facility: Research Site
state: New Jersey
city: Forked River
country: United States
facility: Research Site
state: New Jersey
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Elizabeth City
country: United States
facility: Research Center
state: North Carolina
city: Elizabeth City
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Okalahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma
country: United States
facility: Research Site
state: Oklahoma
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Lake Oswego
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Scranton
country: United States
facility: Research Site
state: Pennsylvania
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: Houston
country: United States
facility: Research Site
state: Texas
city: McKinney
country: United States
facility: Research Site
state: Texas
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Bellingham
country: United States
facility: Research Site
state: Washington
city: Ajax
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Point Edward
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: St. Romuald
country: Canada
facility: Research Site
state: Quebec
city: St. John's
country: Canada
facility: Research Site
Study officials:
References:
citation: 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.