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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00424008 |
Purpose
This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Mometasone furoate/formoterol (MF/F) MDI Drug: Fluticasone propionate/salmeterol (F/SC) DPI |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids |
| Enrollment: | 722 |
| Study Start Date: | April 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MF/F MDI 200/10 mcg BID
Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily.
|
Drug: Mometasone furoate/formoterol (MF/F) MDI
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.
Other Name: SCH 418131
|
|
Active Comparator: F/SC DPI 250/50 mcg BID
Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID
|
Drug: Fluticasone propionate/salmeterol (F/SC) DPI
Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.
Other Name: Advair Diskus in the US/Seretide Diskus outside the US
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00424008 History of Changes |
| Other Study ID Numbers: | P04705, SCH 418131 |
| Study First Received: | January 17, 2007 |
| Results First Received: | June 30, 2010 |
| Last Updated: | December 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Glucocorticosteroids Dry Powder Inhaler Bronchodilator Metered-Dose Inhaler |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Bronchodilator Agents Formoterol Salmeterol Fluticasone Mometasone furoate Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Allergic Agents Anti-Inflammatory Agents Dermatologic Agents |