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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00442117 |
Purpose
This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: mometasone furoate dry powder inhaler Drug: Budesonide DPI |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
MF-DPI: Experimental
MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day)
|
Drug: mometasone furoate dry powder inhaler
MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.
|
|
BUD-DPI: Active Comparator
Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day)
|
Drug: Budesonide DPI
Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If Subjects with ICS treatment have been using ICS on a daily basis for at least 4 weeks prior to Screening. For the two weeks prior to Screening, subjects must have been on a stable regimen of ICS. Each ICS dose is shown in following:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Bryan Wahking, MD - Medical Director, Taiwan Country Operations ) |
| Study ID Numbers: | P04880, SCH 900525 |
| Study First Received: | February 28, 2007 |
| Last Updated: | August 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00442117 History of Changes |
| Health Authority: | Taiwan: Department of Health |
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Anti-Inflammatory Agents Respiratory System Agents Mometasone furoate Physiological Effects of Drugs Budesonide Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Anti-Allergic Agents |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |