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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00442351 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Asmanex twisthaler Other: Placebo for Asmanex twisthaler |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Comparative Study of The Efficacy and Tolerability of Maintenance Treatment of Patients With Mild/Moderate Persistent Asthma With Asmanex Twisthaler 220 Mcg QD PM Versus "Asmanex" Placebo QD PM |
| Enrollment: | 26 |
| Study Start Date: | September 2006 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Asmanex Twisthaler |
Drug: Asmanex twisthaler
Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
Other Name: Mometasone furoate inhalation powder
|
| Placebo Comparator: Placebo inhaler |
Other: Placebo for Asmanex twisthaler
Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00442351 History of Changes |
| Other Study ID Numbers: | P04654, IND Number: 46216; SCH 032088 |
| Study First Received: | February 28, 2007 |
| Results First Received: | March 26, 2010 |
| Last Updated: | March 26, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |