A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults

August 24, 2010 updated by: SkyePharma AG

A Randomized, Double-blind, Active-controlled, Parallel Group, Stratified, Multi-center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™ 250/10ug Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Fluticasone (250ug Twice Daily) Alone in SkyePharma HFA pMDI and Flovent® HFA pMDI in Adolescent and Adult Patients With Moderate to Severe Asthma

The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of two medications in one inhaler. The purpose of this study is to determine how well your asthma is controlled when taking one of the three treatment.

Study Overview

Detailed Description

This Phase 3 randomized, double-blind, active-controlled, parallel group, stratified, multi-center study will evaluate the safety and efficacy of FlutiForm (250/10ug) after twice daily dosing over 12 weeks delivered by SKP HFA pMDI compared with Fluticasone propionate (250ug of twice daily) delivered by SKP HFA pMDI and Flovent® Fluticasone 250ug HFA pMDI in adolescent and adult patients with moderate to severe asthma. Only steroid-requiring patients (inhaled steroid regimen stable for at least 4 weeks prior to the Screening Visit at a dose not greater than 500ug/day Fluticasone propionate or equivalent) will be eligible. All patients will undergo a Run-In Period of 14 ± 3 days during which they will receive asthma maintenance therapy using Fluticasone HFA pMDI (Flovent® HFA 50 ug/actuation: 100µg/day (one inhalation twice daily) if they were using less than or equal to 250mg/day Fluticasone propionate or equivalent inhaled steroid, or 200ug/day (two inhalations twice daily) if they were using greater than 250ug/day Fluticasone propionate or equivalent inhaled steroid prior to the Screening Visit.). The use of rescue Salbutamol (Albuterol) pMDI will be permitted for all patients as needed for the control of worsening asthma symptoms during the Run-In Period. At the Baseline Visit (Week 0) following the Run-In period, eligible patients will be randomized to the treatment groups. Treatment assignment will be stratified according to their Baseline FEV1 % predicted (40-60% or >60-80%).Study drug will be administered twice daily over a 12-week period. Patient visits will occur at Weeks 2, 4, 8, and 12 during which assessments (including serial PFTs up to 4 hours) will be made. In a subset of at least 66 patients (22 patients per treatment group) from selected centers, post-dose 12-hour serial PFTs will be performed at Baseline, Weeks 2 and 12. During the Treatment Period, patients may only take their blinded study medication; all other asthma medications will be withheld for the duration of the Treatment Period. However, the use of rescue Salbutamol (Albuterol) pMDI will be permitted in all patients as needed during the Treatment Period for the control of worsening asthma symptoms.

Study Type

Interventional

Enrollment (Actual)

438

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

      • Bahia Blanca, Argentina, B8000JRB
        • Investigational Site
      • Buenos Aires, Argentina, B1704ESN
        • Investigational Site
      • Buenos Aires, Argentina, C1122AAK
        • Investigational Site
      • Buenos Aires, Argentina, C1426ABO
        • Investigational Site
      • Caba, Argentina, 1035
        • Investigational Site
      • Caba, Argentina, C1121ABE
        • Investigational Site
      • Caba, Argentina, C1122AAK
        • Investigational Site
      • Caba, Argentina, C1405BCH
        • Investigational Site
      • Caba, Argentina, C1425AUA
        • Investigational Site
      • Caba, Argentina, C1437HPA
        • Investigational Site
      • Provincia de Buenos Aires, Argentina, B6500BWQ
        • Investigational Site
      • Salta, Argentina, A4400ERH
        • Investigational Site
      • Santa Fe, Argentina, 2000
        • Investigational Site
      • Santa Fe, Argentina, S2000JKR
        • Investigational Site
      • Tucuman, Argentina, 4000
        • Investigational Site
      • Concepcion, Chile
        • Investigational Site
      • Rancagua, Chile
        • Investigational Site
      • Santiago, Chile
        • Investigational Site
      • Budapest, Hungary, 1122
        • Investigational Site
      • Budapest, Hungary, 1525
        • Investigational Site
      • Deszk, Hungary, 6772
        • Investigational Site
      • Miskolc, Hungary, 3529
        • Investigational Site
      • Miskolc, Hungary, 3526
        • Investigational Site
      • Pecs, Hungary, 7621
        • Investigational Site
      • Chihuahua, Mexico, 31238
        • Investigational Site
      • Guerrero, Mexico, 39670
        • Investigational Site
      • Jalisco, Mexico, 44100
        • Investigational Site
      • Jalisco, Mexico, 45200
        • Investigational Site
      • Luis Encinas S/N, Mexico, 83000
        • Investigational Site
      • Mexico City, Mexico, 06700
        • Investigational Site
      • Mexico City, Mexico, 14050
        • Investigational Site
      • Michoacán, Mexico, 58249
        • Investigational Site
      • Nuevo León, Mexico, 64460
        • Investigational Site
      • Puebla, Mexico, 72190
        • Investigational Site
      • San Bernardino, Mexico
        • Investigational Site
      • Tabasco, Mexico, 86100
        • Investigational Site
      • Cercado de Lima, Peru
        • Investigational Site
      • Cusco, Peru
        • Investigational Site
      • Jesus Maria, Peru
        • Investigational Site
      • Lima, Peru, 31
        • Investigational Site
      • Lima, Peru, 01
        • Investigational Site
      • Lima, Peru, 13
        • Investigational Site
      • Lima, Peru, 27
        • Investigational Site
      • Lima, Peru, 29
        • Investigational Site
      • Lima, Peru, 32
        • Investigational Site
      • Lima, Peru, 33
        • Investigational Site
      • Gdansk, Poland, 80-847
        • Investigational Site
      • Krakow, Poland, 30-901
        • Investigational Site
      • Lodz, Poland
        • Investigational Site
      • Rzeszow, Poland
        • Investigational Site
      • Wroclaw, Poland, 50-434
        • Investigational Site
      • Brasov, Romania, 500326
        • Investigational Site
      • Bucharest, Romania, 030303
        • Investigational Site
      • Bucharest, Romania, 010457
        • Investigational Site
      • Bucharest, Romania, 011172
        • Investigational Site
      • Bucharest, Romania, 021381
        • Investigational Site
      • Bucharest, Romania, 050042
        • Investigational Site
      • Bucuresti, Romania, 050554
        • Investigational Site
      • Craiova, Romania, 200515
        • Investigational Site
      • Palazu Mare, Romania, 9000002
        • Investigational Site
      • Timisoara, Romania
        • Investigational Site
      • Bloemfontein, South Africa, 9301
        • Investigational Site
      • Cape Town, South Africa, 7530
        • Investigational Site
      • Cape Town, South Africa, 7700
        • Investigational Site
      • Durban, South Africa, 4126
        • Investigational Site
      • Pretoria, South Africa, 0157
        • Investigational Site
      • Pretoria, South Africa, 0181
        • Investigational Site
      • Somerset West, South Africa, 7130
        • Investigational Site
      • Tygerberg, South Africa, 7505
        • Investigational Site
      • Dnipropetrovsk, Ukraine, 49017
        • Investigational Site
      • Dnipropetrovsk, Ukraine, 49026
        • Investigational Site
      • Dnipropetrovsk, Ukraine, 49101
        • Investigational Site
      • Donetsk, Ukraine, 83099
        • Investigational Site
      • Donetsk, Ukraine, 83017
        • Investigational Site
      • Kharkiv, Ukraine, 61035
        • Investigational Site
      • Kiev, Ukraine, 02125
        • Investigational Site
      • Kiev, Ukraine, 02232
        • Investigational Site
      • Kiev, Ukraine, 03680
        • Investigational Site
      • Lviv, Ukraine, 79010
        • Investigational Site
      • Vinnytsya, Ukraine, 21029
        • Investigational Site
      • Zaporizhzhya, Ukraine, 69118
        • Investigational Site
      • Zaporizhzhya, Ukraine, 69063
        • Investigational Site
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Investigational Site
      • Tempe, Arizona, United States, 85282
        • Investigational Site
    • California
      • Encinitas, California, United States, 92024
        • Investigational Site
      • Long Beach, California, United States, 90806
        • Investigational Site
      • Orange, California, United States, 92869
        • Investigational Site
    • Florida
      • Oldsmar, Florida, United States, 34677
        • Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Investigational Site
    • Louisiana
      • Metarie, Louisiana, United States, 70006
        • Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Investigational Site
      • Wellesley Hills, Massachusetts, United States, 02481
        • Investigational Site
    • North Carolina
      • Elizabeth City, North Carolina, United States, 27909
        • Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44313
        • Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Investigational Site
      • Providence, Rhode Island, United States, 02906
        • Investigational Site
    • Texas
      • Austin, Texas, United States, 78750
        • Investigational Site
      • El Paso, Texas, United States, 79925
        • Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Investigational Site
    • Wisconsin
      • West Allis, Wisconsin, United States, 53227
        • Investigational 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

Main Inclusion Criteria:

  • ≥ Age 12 years at the Screening Visit.
  • History of asthma for 12 months prior to the Screening Visit.
  • Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Screening Visit.
  • Steroid-requiring patient
  • patients must demonstrate (1) an FEV1 of 40% to 80% (inclusive) of predicted normal values at both the Screening and Baseline Visits and (2) documented reversibility within 12 months of the Screening Visit, defined as a ≥ 15%

Main Exclusion Criteria:

  • Life-threatening asthma within the past year or during the Run-In Period.
  • History of systemic (oral or injectable) corticosteroid medication within 3 months before the Screening Visit.
  • An upper or lower respiratory infection within 4 weeks prior to the Screening Visit or during the Run-In Period.
  • Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis).
  • A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
  • Current smoking history within 12 months prior to the Screening Visit.
  • Previous exposure to FlutiForm

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 250/10ug
SKP 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.
Active Comparator: 2
SKP Fluticasone 250ug
SKP Fluticasone 250 ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Active Comparator: 3
Flovent Fluticasone HFA
Flovent 250 ug HFA is a pMDI that delivers after priming 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Names:
  • Flovent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate the efficacy in terms of the Formoterol fumarate component of SKP FlutiForm HFA pMDI (250/10ug) compared to SKP Fluticasone HFA pMDI (250ug), on the change in FEV1 from morning pre-dose at Baseline (Week 0) to 2 hours post-dose at Week 12.
Time Frame: Week 0 and 12 visits
Week 0 and 12 visits

Secondary Outcome Measures

Outcome Measure
Time Frame
Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) compared to FLOVENT® Fluticasone pMDI (250ug) on the change in FEV1 from morning pre-dose at Baseline (Week 0) to 2 hours post-dose at Week 12.
Time Frame: Week 0 and 12 visits
Week 0 and 12 visits
Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) using other pulmonary function tests (PFTs), and clinical endpoints.
Time Frame: Whole duration of study
Whole duration of study
Assess the safety profile of SKP FLUTIFORM HFA pMDI (250/10ug twice daily) using incidence of adverse events, and changes in electrocardiograms, clinical laboratory tests and vital signs.
Time Frame: Whole duration of study
Whole duration of study
To assess the 12-hour serial FEV1 area under the curve (AUC) in a subset population (in a minimum of 66 patients).
Time Frame: Week 0; 2 and 12 visits
Week 0; 2 and 12 visits

Collaborators and Investigators

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

Sponsor

Collaborators

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.

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

March 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

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.

Clinical Trials on Asthma

Clinical Trials on FlutiForm 250/10

3
Subscribe