CLINICAL TRIALS PROFILE FOR ASMANEX HFA
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All Clinical Trials for ASMANEX HFA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00394355 ↗ | Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418) | Completed | Merck Sharp & Dohme Corp. | Phase 4 | 2006-09-01 | This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two scan results prior to treatment) to the endpoint of treatment time point (the average of the last two valid post-baseline scan results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus montelukast (ML) 10 mg daily in the evening. |
| NCT00442117 ↗ | A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2007-06-01 | 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. |
| NCT00442351 ↗ | Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED) | Terminated | Merck Sharp & Dohme Corp. | Phase 4 | 2006-09-01 | This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study). |
| NCT00461812 ↗ | A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma | Terminated | Schering-Plough | Phase 4 | 2007-04-01 | The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma? The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma. |
| NCT00461812 ↗ | A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma | Terminated | Johns Hopkins University | Phase 4 | 2007-04-01 | The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma? The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma. |
| NCT00521599 ↗ | A Study of the Equivalent Effectiveness of 400 mcg Mometasone Furoate Using Two Different Dry Powder Inhalers in Moderate Asthmatics (Study P04828) | Completed | Merck Sharp & Dohme Corp. | Phase 4 | 2007-05-01 | This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers, preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation of MF DPI 200 mcg twice daily in corticosteroid-dependent asthmatic subjects. The objective of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs when providing the same total daily dose (400 mcg/day). |
| NCT00711165 ↗ | Mometasone and Markers of Airway Inflammation | Completed | Schering-Plough | Phase 4 | 2005-08-01 | A post-marketing study to look at the effects of Asmanex on markers of airway inflammation. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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