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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00394355 |
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.
Condition | Intervention | Phase |
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Asthma |
Drug: mometasone furoate dry powder inhaler Drug: fluticasone propionate HFA Drug: montelukast |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study |
Official Title: | Comparative Study of the Effect of Two Doses of Mometasone Furoate Dry Powder Inhaler 200 Mcg and 400 Mcg QD PM, Fluticasone Propionate 250 Mcg BID, and Montelukast 10 mg QD PM, on Bone Mineral Density in Adults With Asthma |
Estimated Enrollment: | 560 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
MF DPI 400 mcg QD PM
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Drug: mometasone furoate dry powder inhaler
400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
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Group 2: Experimental
MF DPI 200 mcg QD PM
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Drug: mometasone furoate dry powder inhaler
200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
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Group 3: Active Comparator
FP MDI 250 mcg BID
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Drug: fluticasone propionate HFA
250 mcg FP HFA given twice a day via a metered-dose inhaler and a placebo tablet given once daily in the evening for 1 year
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Group 4: Active Comparator
ML 10 mg QD PM
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Drug: montelukast
10 mg given once daily in the evening by mouth for 1 year.
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Group 5: Active Comparator
ML 10 mg QD PM; having a second montelukast arm allows for double-blind conditions by inhaler.
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Drug: montelukast
10 mg given once daily in the evening by mouth for 1 year; having a second montelukast arm allows for double-blind conditions by inhaler.
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P03418, Doc ID: 3387777;, EUDRACT No: 2004-002930-21; |
Study First Received: | October 31, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00394355 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Montelukast Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Mometasone furoate Lung Diseases |
Hypersensitivity, Immediate Fluticasone Asthma Leukotriene Antagonists Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents |