Trials / Completed
CompletedNCT00442117
A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)
A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mometasone furoate dry powder inhaler | MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks. |
| DRUG | Budesonide DPI | Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks. |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2009-07-01
- Completion
- 2009-07-01
- First posted
- 2007-03-01
- Last updated
- 2024-05-20
- Results posted
- 2011-02-10
Source: ClinicalTrials.gov record NCT00442117. Inclusion in this directory is not an endorsement.