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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394199
• Other study ID #: SKY2028-3-002
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2006
• Last updated: June 8, 2011
• Start date: June 2006
• Est. completion date: February 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: February 2008
• Est. primary completion date: February 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 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.

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 100 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.

Locations

Country	Name	City	State
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kelowna	British Columbia
Canada	Research Center	London	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Longueuil	Quebec
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Saint Foy	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois Rivieres	Quebec
Canada	Research Site	Vancouver	British Columbia
United States	Research Site	Asheville	North Carolina
United States	Research Site	Bethesda	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Easton	Pennsylvania
United States	Research Site	El Paso	Texas
United States	Research Site	Elizabeth	New Jersey
United States	Research Site	Greenfield	Wisconsin
United States	Research Site	Greenville	South Carolina
United States	Research Site	Houston	Texas
United States	Research Site	Katy	Texas
United States	Research Site	Lilburn	Georgia
United States	Research Site	Lincoln	Rhode Island
United States	Research Site	Mission Viejo	California
United States	Research Site	N. Dartmouth	Massachusetts
United States	Research Site	New Braunfels	Texas
United States	Research Site	Orange	California
United States	Research Site	Park City	Kansas
United States	Research Site	Raleigh	North Carolina
United States	Research Center	Rochester	New York
United States	Research Site	San Jose	California
United States	Research Site	Savannah	Georgia
United States	Research Site	South Burlington	Vermont
United States	Research Center	Stevensville	Michigan
United States	Research Site	Sylvania	Ohio
United States	Research Site	Vista	California
United States	Research Site	Waco	Texas

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) from morning predose at Baseline (Week 0) to predose at Week 12		Week 0 and 12	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 include adverse events, ECGs, clinical laboratory tests and vital signs.		Whole duration of study	Yes