Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393991
• Other study ID #: SKY2028-3-001
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2006
• Last updated: June 8, 2011
• Start date: July 2006
• Est. completion date: April 2008

Study information

• Verified date: June 2011
• Source: SkyePharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone propionate/formoterol fumarate 100/10
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 propionate 100
Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
• Formoterol fumarate 10
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
• Placebo
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.

Locations

Country	Name	City	State
Canada	Research Site	Ajax	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Point Edward	Ontario
Canada	Research Site	St. John's
Canada	Research Site	St. Romuald	Quebec
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
United States	Research Site	Asheville	North Carolina
United States	Research Site	Austin	Texas
United States	Research Site	Aventura	Florida
United States	Research Site	Bellingham	Washington
United States	Research Site	Bethesda	Maryland
United States	Research Site	Brockton	Massachusetts
United States	Research Site	Centennial	Colorado
United States	Research Site	Cherry Hill	New Jersey
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbus	Ohio
United States	Research Site	Conyers	Georgia
United States	Research Site	Cypress	California
United States	Research Site	Dallas	Texas
United States	Research Site	El Paso	Texas
United States	Research Center	Elizabeth City	North Carolina
United States	Research Site	Elizabeth City	North Carolina
United States	Research Site	Encinitas	California
United States	Research Site	Englewood	Colorado
United States	Research Site	Eugene	Oregon
United States	Research Site	Forked River	New Jersey
United States	Research Site	Fountain Valley	California
United States	Research Site	Gainesville	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Lake Oswego	Oregon
United States	Research Center	Largo	Florida
United States	Research Site	Lawrenceville	Georgia
United States	Research Center	Los Angeles	California
United States	Research Site	McKinney	Texas
United States	Research Site	Medford	Oregon
United States	Research Site	Miami	Florida
United States	Research Site	Mission Hills	California
United States	Research Site	Ocala	Florida
United States	Research Site	Okalahoma City	Oklahoma
United States	Research Site	Oklahoma	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Pell City	Alabama
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Round Lake Beach	Illinois
United States	Research Site	Round Rock	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Scranton	Pennsylvania
United States	Research Site	Tallahassee	Florida
United States	Research Site	Toledo	Ohio
United States	Research Site	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
SkyePharma AG

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR).		Whole duration of study	No
Secondary	Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).		Whole duration of study	No
Secondary	Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs.		Whole duration of study	Yes
Secondary	Serial 12-hour FEV-1 area under the curve (AUC).		Week 0, 2 and 12 visits	No