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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 |
MedlinePlus related topics: | Asthma |
ChemIDplus related topics: | Fluticasone propionate Fluticasone Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Mometasone furoate Salmeterol Salmeterol xinafoate |
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 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (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.
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Drug: Mometasone furoate/formoterol (MF/F) combination
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.
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F/SC DPI 250/50 mcg BID: Active Comparator
Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID
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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.
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Show 114 Study Locations |
Schering-Plough |
Study Director: | Hendrik Nolte, MD, PhD | Allergy/Respiratory Diseases/Clinical Immunology, Schering-Plough |
Responsible Party: | Schering-Plough ( Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology ) |
Study ID Numbers: | P04705, SCH 418131 |
First Received: | January 17, 2007 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00424008 |
Health Authority: | United States: Food and Drug Administration |
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