| February 28, 2007 |
| August 26, 2009 |
| November 2006 |
| July 2009 (final data collection date for primary outcome measure) |
| The primary endpoint for the study is the percent change from baseline in FEV1. [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00442117 on ClinicalTrials.gov Archive Site |
| Change from baseline in FVC, FEF(25%-75%), AM PEFR, nocturnal and daytime asthma symptoms based on a 4-point scale, assessment of response to therapy based on a 5-point scale, and the number of puffs of rescue medication. [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ] |
| Same as current |
| |
| A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)(COMPLETED) |
| A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients |
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. |
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| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Asthma |
- Drug: mometasone furoate dry powder inhaler
- Drug: Budesonide DPI
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- Experimental: MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day)
- Active Comparator: Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day)
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| |
| |
| Completed |
| 200 |
| July 2009 |
| July 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- Female subjects who are pregnant, breast-feeding, or are pre-menarcheal.
- Subjects who are heavy smokers (more than 10 pack years) or who smoked within previous 6 months.
- Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 3 months immediately prior to the Screening visit, and/or subjects who have required a course of systemic corticosteroids within the previous month.
- Subjects who used Leukotriene modifiers within 2 weeks of screening.
- Subjects who took immunosuppressive agents within the previous 3 months.
- Subjects who use daily nebulized ß2-adrenergic agonists.
- Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks.
- Subjects who have been admitted to the hospital for asthma control within the previous 3 months or have needed emergency service for asthma more than once within the previous 6 months.
- Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years.
- Subjects who have used any investigational drug in the 30 days prior to Baseline, or subjects who have been treated with any investigational antibody for asthma in the 90 days prior to Baseline.
- Subjects who are allergic or have had an idiosyncratic reaction to corticosteroids.
- Subjects with evidence of clinically significant oropharyngeal candidiasis at Screening or Baseline.
- Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system, or respiratory disease other than asthma (e.g. COPD), or any other disorder which may interfere with the study evaluations or affect subject safety.
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| Both |
| 12 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
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| NCT00442117 |
| Bryan Wahking, MD - Medical Director, Taiwan Country Operations, Schering-Plough |
| P04880, SCH 900525 |
| Schering-Plough |
|
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| Schering-Plough |
| August 2009 |