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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393952
• Other study ID #: SKY2028-3-004
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2006
• Last updated: June 8, 2011
• Start date: June 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 with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• 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

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.

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 250/10
FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 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.
• 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 250
Fluticasone 250 is a HFA pMDI that delivers 125ug 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.

Locations

Country	Name	City	State
Puerto Rico	Research Center	Ponce
United States	Research Center	Anderson	South Carolina
United States	Research Site	Ashland	Oregon
United States	Research Site	Austin	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bozeman	Montana
United States	Research Site	Brick	New Jersey
United States	Research Site	Burbank	California
United States	Research Center	Congers	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	El Paso	Texas
United States	Research Center	Fort Worth	Texas
United States	Research Site	Fresno	California
United States	Research Center	Gainesville	Florida
United States	Research Site	Glendale	Arizona
United States	Research Site	Greenville	South Carolina
United States	Research Site	Hialeah	Florida
United States	Research Site	Jonesboro	Arkansas
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lincoln	Rhode Island
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Long Beach	California
United States	Research Center	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Medford	Oregon
United States	Research Site	Milwaukee	Wisconsin
United States	Research Center	Minneapolis	Minnesota
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Mission Viejo	California
United States	Research Site	Monterey Park	California
United States	Research Site	Mt. Laurel	New Jersey
United States	Research Site	N. Dartmouth	Massachusetts
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Ormond Beach	Florida
United States	Research Site	Palmdale	California
United States	Research Center	Panama City	Florida
United States	Research Center	Pell City	Alabama
United States	Research Site	Pensacola	Florida
United States	Research Center	Phoenix	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Plymouth	Minnesota
United States	Research Center	Portland	Oregon
United States	Research Site	Richmond	Virginia
United States	Research Site	Rockville Centre	New York
United States	Research Site	Round Lake Beach	Illinois
United States	Research Site	Sacramento	California
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	San Jose	California
United States	Research Site	Savannah	Georgia
United States	Research Site	Skillman	New Jersey
United States	Research Site	St. Louis	Missouri
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Taunton	Massachusetts
United States	Research Site	Tinton Falls	New Jersey
United States	Research Site	Tucson	Arizona
United States	Research Center	Upland	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
SkyePharma AG

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12.		Week 0 and 12 visits	No
Primary	Discontinuation due to lack of efficacy.		Whole duration of study	No
Secondary	Other pulmonary function tests including forced vial 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	Serial 12-hour FEV-1 area under the curve (AUC).		Week 0, 2 and 12 visits	No
Secondary	Safety variables including adverse events, ECGs clinical laboratory tests and vital signs.		Whole duration of study	Yes