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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00394355 |
Purpose
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 |
|---|---|---|
|
Asthma |
Drug: mometasone furoate dry powder inhaler Drug: fluticasone propionate hydrofluoroalkane (HFA) Drug: montelukast |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 566 |
| Study Start Date: | November 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
MF DPI 400 mcg once a day (QD) in the evening (PM)
|
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.
Other Name: Asmanex
|
|
Experimental: Group 2
MF DPI 200 mcg QD PM
|
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.
Other Name: Asmanex
|
|
Active Comparator: Group 3
Fluticasone propionate (FP) metered dose inhaler (MDI) 250 mcg twice a day (BID)
|
Drug: fluticasone propionate hydrofluoroalkane (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
Other Name: Flovent HFA
|
|
Active Comparator: Group 4
ML 10 mg QD PM
|
Drug: montelukast
10 mg given once daily in the evening by mouth for 1 year.
Other Name: Singulair
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00394355 History of Changes |
| Other Study ID Numbers: | P03418, Doc ID: 3387777;, EUDRACT No: 2004-002930-21; |
| Study First Received: | October 31, 2006 |
| Results First Received: | October 22, 2010 |
| Last Updated: | February 10, 2011 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Mometasone furoate Fluticasone Montelukast Anti-Allergic Agents |
Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |