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

Condition(s) targeted: Asthma

Intervention: FlutiForm 250/10 (Drug); SKP-Fluticasone (Drug); Flovent Fluticasone HFA (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: SkyePharma AG

Overall contact:
Mary E Venetucci, Phone: 847 937 9329, Email: mary.venetucci@abbott.com

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

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.

Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) using other pulmonary function tests (PFTs), and clinical endpoints.

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.

To assess the 12-hour serial FEV1 area under the curve (AUC) in a subset population (in a minimum of 66 patients).

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.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Mary E Venetucci, Phone: 847 937 9329, Email: mary.venetucci@abbott.com

Investigational Site, Caba C1405BCH, Argentina; Recruiting
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Investigational Site, Tucuman 4000, Argentina; Recruiting
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Investigational Site, Provincia de Buenos Aires B6500BWQ, Argentina; Recruiting
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Investigational Site, Santa Fe S2000JKR, Argentina; Recruiting
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Investigational Site, Caba 1035, Argentina; Recruiting
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Investigational Site, Buenos Aires C1122AAK, Argentina; Recruiting
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Investigational Site, Salta A4400ERH, Argentina; Recruiting
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Investigational Site, Caba C1121ABE, Argentina; Recruiting
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Investigational Site, CABA C1425AUA, Argentina; Recruiting
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Investigational Site, Buenos Aires C1426ABO, Argentina; Recruiting
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Investigational Site, Bahia Blanca B8000JRB, Argentina; Recruiting
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Investigational Site, Buenos Aires B1704ESN, Argentina; Recruiting
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Investigational Site, Santa Fe 2000, Argentina; Recruiting
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Investigational Site, Caba C1122AAK, Argentina; Not yet recruiting
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Investigational Site, Caba C1437HPA, Argentina; Not yet recruiting
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Investigational Site, Rancagua, Chile; Not yet recruiting
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Investigational Site, Concepcion, Chile; Not yet recruiting
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Investigational Site, Santiago, Chile; Not yet recruiting
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Investigational Site, Deszk 6772, Hungary; Not yet recruiting
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Investigational Site, Miskolc 3526, Hungary; Not yet recruiting
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Investigational Site, Miskolc 3529, Hungary; Not yet recruiting
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Investigational Site, Budapest 1525, Hungary; Not yet recruiting
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Investigational Site, Budapest 1122, Hungary; Not yet recruiting
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Investigational Site, Pecs 7621, Hungary; Not yet recruiting
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Investigational Site, Guerrero 39670, Mexico; Recruiting
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Investigational Site, Mexico City 06700, Mexico; Not yet recruiting
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Investigational Site, Jalisco 44100, Mexico; Recruiting
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Investigational Site, Mexico City 14050, Mexico; Not yet recruiting
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Investigational Site, Michoacán 58249, Mexico; Not yet recruiting
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Investigational Site, Jalisco 45200, Mexico; Not yet recruiting
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Investigational Site, Puebla 72190, Mexico; Not yet recruiting
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Investigational Site, Nuevo León 64460, Mexico; Not yet recruiting
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Investigational Site, Tabasco 86100, Mexico; Not yet recruiting
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Investigational Site, Luis Encinas S/N 83000, Mexico; Not yet recruiting
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Investigational Site, Chihuahua 31238, Mexico; Not yet recruiting
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Investigational Site, San Bernardino, Mexico; Not yet recruiting
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Investigational Site, Lima 29, Peru; Not yet recruiting
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Investigational Site, Lima 13, Peru; Not yet recruiting
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Investigational Site, Lima 01, Peru; Not yet recruiting
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Investigational Site, Lima 33, Peru; Not yet recruiting
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Investigational Site, Lima 27, Peru; Not yet recruiting
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Investigational Site, Lima 31, Peru; Not yet recruiting
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Investigational Site, Lima 32, Peru; Not yet recruiting
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Investigational Site, Cercado de Lima, Peru; Not yet recruiting
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Investigational Site, Jesus Maria, Peru; Not yet recruiting
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Investigational Site, Cusco, Peru; Not yet recruiting
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Investigational Site, Wroclaw 50-434, Poland; Not yet recruiting
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Investigational Site, Gdansk 80-847, Poland; Not yet recruiting
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Investigational Site, Krakow 30-901, Poland; Not yet recruiting
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Investigational Site, Rzeszow, Poland; Not yet recruiting
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Investigational Site, Lodz, Poland; Not yet recruiting
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Investigational Site, Palazu Mare 9000002, Romania; Recruiting
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Investigational Site, Bucharest 010457, Romania; Recruiting
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Investigational Site, Bucharest 030303, Romania; Recruiting
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Investigational Site, Craiova 200515, Romania; Not yet recruiting
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Investigational Site, Bucuresti 050554, Romania; Not yet recruiting
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Investigational Site, Brasov 500326, Romania; Not yet recruiting
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Investigational Site, Bucharest 050042, Romania; Not yet recruiting
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Investigational Site, Bucharest 011172, Romania; Not yet recruiting
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Investigational Site, Timisoara, Romania; Not yet recruiting
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Investigational Site, Bucharest 021381, Romania; Not yet recruiting
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Investigational Site, Tygerberg 7505, South Africa; Not yet recruiting
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Investigational Site, Cape Town 7530, South Africa; Not yet recruiting
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Investigational Site, Pretoria 0181, South Africa; Not yet recruiting
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Investigational Site, Somerset West 7130, South Africa; Not yet recruiting
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Investigational Site, Pretoria 0157, South Africa; Not yet recruiting
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Investigational Site, Bloemfontein 9301, South Africa; Not yet recruiting
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Investigational Site, Durban 4126, South Africa; Not yet recruiting
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Investigational Site, Cape Town 7700, South Africa; Not yet recruiting
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Investigational Site, Kharkiv 61035, Ukraine; Recruiting
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Investigational Site, Kiev 03680, Ukraine; Recruiting
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Investigational Site, Kiev 02125, Ukraine; Recruiting
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Investigational Site, Donetsk 83099, Ukraine; Recruiting
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Investigational Site, Kiev 02232, Ukraine; Not yet recruiting
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Investigational Site, Zaporizhzhya 69118, Ukraine; Recruiting
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Investigational Site, Dnipropetrovsk 49026, Ukraine; Recruiting
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Investigational Site, Vinnytsya 21029, Ukraine; Recruiting
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Investigational Site, Lviv 79010, Ukraine; Recruiting
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Investigational Site, Dnipropetrovsk 49101, Ukraine; Not yet recruiting
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Investigational Site, Donetsk 83017, Ukraine; Not yet recruiting
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Investigational Site, Dnipropetrovsk 49017, Ukraine; Not yet recruiting
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Investigational Site, Zaporizhzhya 69063, Ukraine; Not yet recruiting
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Investigational site, Scottsdale, Arizona 85251, United States; Recruiting
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Investigational Site, Tempe, Arizona 85282, United States; Recruiting
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Investigational site, Long Beach, California 90806, United States; Recruiting
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Investigational site, Orange, California 92869, United States; Recruiting
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Investigational Site, Encinitas, California 92024, United States; Recruiting
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Investigational Site, Oldsmar, Florida 34677, United States; Recruiting
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Investigational Site, Indianapolis, Indiana 46208, United States; Recruiting
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Investigational site, Crestview Hills, Kentucky 41017, United States; Recruiting
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Investigational Site, Metarie, Louisiana 70006, United States; Recruiting
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Investigational site, North Dartmouth, Massachusetts 02747, United States; Recruiting
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Investigational Site, Wellesley Hills, Massachusetts 02481, United States; Recruiting
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Investigational site, Elizabeth City, North Carolina 27909, United States; Recruiting
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Investigational site, Cincinnati, Ohio 45227, United States; Recruiting
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Investigational Site, Akron, Ohio 44313, United States; Recruiting
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Investigational Site, Portland, Oregon 97213, United States; Recruiting
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Investigational site, Providence, Rhode Island 02906, United States; Recruiting
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Investigational Site, East Providence, Rhode Island 02914, United States; Recruiting
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Investigational site, El Paso, Texas 79925, United States; Recruiting
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Investigational Site, Austin, Texas 78750, United States; Recruiting
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Investigational site, Richmond, Virginia 23229, United States; Recruiting
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Investigational Site, West Allis, Wisconsin 53227, United States; Recruiting
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Starting date: March 2008
Ending date: October 2008
Last updated: May 29, 2008