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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00442351 |
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) PM compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in FEV1 from Baseline to the end of treatment period (Week 12 or end of the study).
Condition | Intervention | Phase |
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Asthma |
Drug: Asmanex Twisthaler |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Has symptomatic allergic rhinitis (total nasal and non-nasal symptom severity score >= 4) noted at the Screening and Baseline Visits (Visits
1, 2, and 3). (During any phase of the study, subjects who become symptomatic with allergic rhinitis can be treated with a nonsedating antihistamine and/or inhaled nasal corticosteroid. Allergic rhinitis severity should be rated and the score recorded in the diary at the initiation of this illness.
Study ID Numbers: | P04654, IND Number: 46216; SCH 032088 |
Study First Received: | February 28, 2007 |
Last Updated: | August 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00442351 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Mometasone furoate |
Lung Diseases Hypersensitivity, Immediate Asthma Anti-Allergic Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Bronchial Diseases Immune System Diseases Mometasone furoate Asthma Anti-Allergic Agents Pharmacologic Actions |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity |