Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Schering-Plough |
---|---|
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00424008 |
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) combination Drug: Fluticasone propionate and salmeterol (F/SC) DPI |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 664 |
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 |
---|---|
MF/F MDI 200/10 mcg BID: Experimental
Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily.
|
Drug: Mometasone furoate/formoterol (MF/F) combination
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.
|
F/SC DPI 250/50 mcg BID: Active Comparator
Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID
|
Drug: Fluticasone propionate and salmeterol (F/SC) DPI
Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.
|
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04705, SCH 418131 |
Study First Received: | January 17, 2007 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00424008 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Glucocorticosteroids Dry Powder Inhaler Bronchodilator Metered-Dose Inhaler |
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Mometasone furoate Anti-Asthmatic Agents Asthma Anti-Allergic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Formoterol Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchial Diseases Adrenergic Agents Physiological Effects of Drugs Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Fluticasone Formoterol Dermatologic Agents |
Salmeterol Immune System Diseases Adrenergic beta-Agonists Mometasone furoate Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |