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

June 8, 2011 updated by: SkyePharma AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 9L8
        • Research Site
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Research Site
      • London, Ontario, Canada, N6A 1V2
        • Research Site
      • London, Ontario, Canada, N5X 4E7
        • Research Center
      • Mississauga, Ontario, Canada, L4W 1N2
        • Research Site
      • Oshawa, Ontario, Canada, L1H 1B9
        • Research Site
      • Toronto, Ontario, Canada, M4P 1P2
        • Research Site
    • Quebec
      • Longueuil, Quebec, Canada, J4N 1E1
        • Research Site
      • Montreal, Quebec, Canada, H2L 2W5
        • Research Site
      • Saint Foy, Quebec, Canada, G1V 4M6
        • Research Site
      • Trois Rivieres, Quebec, Canada, G8T 7A1
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Research Site
    • California
      • Mission Viejo, California, United States, 92691
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
      • San Jose, California, United States, 95117
        • Research Site
      • Vista, California, United States, 92083
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80230
        • Research Site
    • Georgia
      • Lilburn, Georgia, United States, 30047
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Research Site
    • Kansas
      • Park City, Kansas, United States, 67219
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Research Site
    • Massachusetts
      • N. Dartmouth, Massachusetts, United States, 02747
        • Research Site
    • Michigan
      • Stevensville, Michigan, United States, 49127
        • Research Center
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
        • Research Site
    • New York
      • Rochester, New York, United States, 14618
        • Research Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Research Site
      • Raleigh, North Carolina, United States, 27607
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Sylvania, Ohio, United States, 43560
        • Research Site
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Research Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02906
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Research Site
    • Texas
      • El Paso, Texas, United States, 79902
        • Research Site
      • Houston, Texas, United States, 77054
        • Research Site
      • Katy, Texas, United States, 77450
        • Research Site
      • New Braunfels, Texas, United States, 78130
        • Research Site
      • Waco, Texas, United States, 76712
        • Research Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Research Site
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
FlutiForm 100/10ug
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.
Other Names:
  • Flutiform 100/10
Experimental: 2
Fluticasone 100
Drug: 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.
Other Names:
  • Fluticasone 100
Active Comparator: 3
Formoterol 10
Drug: 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.
Other Names:
  • SKP Formoterol 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12
Time Frame: Week 0 and 12
Week 0 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR).
Time Frame: Whole duration of study
Whole duration of study
Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).
Time Frame: Whole duration of study
Whole duration of study
Safety variables include adverse events, ECGs, clinical laboratory tests and vital signs.
Time Frame: Whole duration of study
Whole duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SkyePharma AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 27, 2006

First Submitted That Met QC Criteria

October 30, 2006

First Posted (Estimate)

October 31, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKY2028-3-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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