Clinical trial NCT00394199: Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
Official title: 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
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: 357
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: 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.


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 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12
timeFrame: Week 0 and 12
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 include adverse events, ECGs, clinical laboratory tests and vital signs.
timeFrame: Whole duration of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Jose
country: United States
facility: Research Site
state: California
city: Vista
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Lilburn
country: United States
facility: Research Site
state: Georgia
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Park City
country: United States
facility: Research Site
state: Kansas
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: N. Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Stevensville
country: United States
facility: Research Center
state: Michigan
city: Elizabeth
country: United States
facility: Research Site
state: New Jersey
city: Rochester
country: United States
facility: Research Center
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Sylvania
country: United States
facility: Research Site
state: Ohio
city: Easton
country: United States
facility: Research Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Research Site
state: Rhode Island
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Katy
country: United States
facility: Research Site
state: Texas
city: New Braunfels
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: South Burlington
country: United States
facility: Research Site
state: Vermont
city: Greenfield
country: United States
facility: Research Site
state: Wisconsin
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Center
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Longueuil
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Saint Foy
country: Canada
facility: Research Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: Research Site
state: Quebec
Study officials:
References:
citation: 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.