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Sponsors and Collaborators: |
SkyePharma AG Abbott MDS Pharma Services |
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Information provided by: | SkyePharma AG |
ClinicalTrials.gov Identifier: | NCT00649025 |
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.
Condition | Intervention | Phase |
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Asthma |
Drug: FlutiForm 250/10 Drug: SKP-Fluticasone Drug: Flovent Fluticasone HFA |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 438 |
Study Start Date: | March 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
FlutiForm 250/10ug
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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.
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2: Active Comparator
SKP Fluticasone 250ug
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Drug: 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.
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3: Active Comparator
Flovent Fluticasone HFA
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Drug: 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.
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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.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Responsible Party: | SkyePharma AG ( SkyePharma AG ) |
Study ID Numbers: | SKY2028-3-005 |
Study First Received: | March 28, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00649025 |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Mexico, Peru, Poland, Ukraine: Ministry of Health; Romania: National Medicines Agency; South Africa: Medicines Control Council |
Asthma Asthma Moderate to Severe |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate |
Formoterol Fluticasone Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Anti-Allergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |