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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649025
• Other study ID #: SKY2028-3-005
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2008
• Last updated: August 24, 2010
• Start date: March 2008
• Est. completion date: October 2008

Study information

• Verified date: August 2010
• Source: SkyePharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaCanada: Health CanadaChile: Instituto de Salud Pública de ChileCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyMexico, Peru, Poland, Ukraine: Ministry of HealthRomania: National Medicines AgencySouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 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:
• FlutiForm 250/10
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.
• SKP-Fluticasone
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.
• 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.

Locations

Country	Name	City	State
Argentina	Investigational Site	Bahia Blanca
Argentina	Investigational Site	Buenos Aires
Argentina	Investigational Site	Buenos Aires
Argentina	Investigational Site	Buenos Aires
Argentina	Investigational Site	Caba
Argentina	Investigational Site	Caba
Argentina	Investigational Site	Caba
Argentina	Investigational Site	Caba
Argentina	Investigational Site	Caba
Argentina	Investigational Site	Caba
Argentina	Investigational Site	Provincia de Buenos Aires
Argentina	Investigational Site	Salta
Argentina	Investigational Site	Santa Fe
Argentina	Investigational Site	Santa Fe
Argentina	Investigational Site	Tucuman
Chile	Investigational Site	Concepcion
Chile	Investigational Site	Rancagua
Chile	Investigational Site	Santiago
Hungary	Investigational Site	Budapest
Hungary	Investigational Site	Budapest
Hungary	Investigational Site	Deszk
Hungary	Investigational Site	Miskolc
Hungary	Investigational Site	Miskolc
Hungary	Investigational Site	Pecs
Mexico	Investigational Site	Chihuahua
Mexico	Investigational Site	Guerrero
Mexico	Investigational Site	Jalisco
Mexico	Investigational Site	Jalisco
Mexico	Investigational Site	Luis Encinas S/N
Mexico	Investigational Site	Mexico City
Mexico	Investigational Site	Mexico City
Mexico	Investigational Site	Michoacán
Mexico	Investigational Site	Nuevo León
Mexico	Investigational Site	Puebla
Mexico	Investigational Site	San Bernardino
Mexico	Investigational Site	Tabasco
Peru	Investigational Site	Cercado de Lima
Peru	Investigational Site	Cusco
Peru	Investigational Site	Jesus Maria
Peru	Investigational Site	Lima
Peru	Investigational Site	Lima
Peru	Investigational Site	Lima
Peru	Investigational Site	Lima
Peru	Investigational Site	Lima
Peru	Investigational Site	Lima
Peru	Investigational Site	Lima
Poland	Investigational Site	Gdansk
Poland	Investigational Site	Krakow
Poland	Investigational Site	Lodz
Poland	Investigational Site	Rzeszow
Poland	Investigational Site	Wroclaw
Romania	Investigational Site	Brasov
Romania	Investigational Site	Bucharest
Romania	Investigational Site	Bucharest
Romania	Investigational Site	Bucharest
Romania	Investigational Site	Bucharest
Romania	Investigational Site	Bucharest
Romania	Investigational Site	Bucuresti
Romania	Investigational Site	Craiova
Romania	Investigational Site	Palazu Mare
Romania	Investigational Site	Timisoara
South Africa	Investigational Site	Bloemfontein
South Africa	Investigational Site	Cape Town
South Africa	Investigational Site	Cape Town
South Africa	Investigational Site	Durban
South Africa	Investigational Site	Pretoria
South Africa	Investigational Site	Pretoria
South Africa	Investigational Site	Somerset West
South Africa	Investigational Site	Tygerberg
Ukraine	Investigational Site	Dnipropetrovsk
Ukraine	Investigational Site	Dnipropetrovsk
Ukraine	Investigational Site	Dnipropetrovsk
Ukraine	Investigational Site	Donetsk
Ukraine	Investigational Site	Donetsk
Ukraine	Investigational Site	Kharkiv
Ukraine	Investigational Site	Kiev
Ukraine	Investigational Site	Kiev
Ukraine	Investigational Site	Kiev
Ukraine	Investigational Site	Lviv
Ukraine	Investigational Site	Vinnytsya
Ukraine	Investigational Site	Zaporizhzhya
Ukraine	Investigational Site	Zaporizhzhya
United States	Investigational Site	Akron	Ohio
United States	Investigational Site	Austin	Texas
United States	Investigational site	Cincinnati	Ohio
United States	Investigational site	Crestview Hills	Kentucky
United States	Investigational Site	East Providence	Rhode Island
United States	Investigational site	El Paso	Texas
United States	Investigational site	Elizabeth City	North Carolina
United States	Investigational Site	Encinitas	California
United States	Investigational Site	Indianapolis	Indiana
United States	Investigational site	Long Beach	California
United States	Investigational Site	Metarie	Louisiana
United States	Investigational site	North Dartmouth	Massachusetts
United States	Investigational Site	Oldsmar	Florida
United States	Investigational site	Orange	California
United States	Investigational Site	Portland	Oregon
United States	Investigational site	Providence	Rhode Island
United States	Investigational site	Richmond	Virginia
United States	Investigational site	Scottsdale	Arizona
United States	Investigational Site	Tempe	Arizona
United States	Investigational Site	Wellesley Hills	Massachusetts
United States	Investigational Site	West Allis	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
SkyePharma AG	Abbott, MDS Pharma Services

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Hungary,  Mexico,  Peru,  Poland,  Romania,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Week 0 and 12 visits	No
Secondary	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.		Week 0 and 12 visits	No
Secondary	Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) using other pulmonary function tests (PFTs), and clinical endpoints.		Whole duration of study	No
Secondary	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.		Whole duration of study	Yes
Secondary	To assess the 12-hour serial FEV1 area under the curve (AUC) in a subset population (in a minimum of 66 patients).		Week 0; 2 and 12 visits	No