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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00599027 |
The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of allergic rhinitis and asthma.
Condition | Intervention | Phase |
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Allergic Rhinitis Asthma |
Drug: Mometasone furoate nasal spray (MFNS) Drug: Matching placebo nasal spray |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Exploratory Study of Mometasone Furoate Nasal Spray in Patients With Moderate-Severe Persistent Allergic Rhinitis and Intermittent Asthma: Effects on the Quality of Life Evaluated With the Rhinasthma Questionnaire |
Estimated Enrollment: | 56 |
Study Start Date: | May 2008 |
Study Completion Date: | April 2009 |
Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Mometasone furoate nasal spray 200 mcg QD: Experimental |
Drug: Mometasone furoate nasal spray (MFNS)
MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD)
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Matching placebo nasal spray: Placebo Comparator |
Drug: Matching placebo nasal spray
Matching placebo nasal spray: 2 sprays in each nostril once daily.
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The primary objective is to explore the efficacy of mometasone furoate nasal spray (MFNS) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). In addition, there are two secondary objectives. The first secondary objective is to evaluate the efficacy of MFNS in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Upper Airways Score, the Rhinasthma Lower Airways Score, and the Rhinasthma Respiratory Allergy Impact Score. The second secondary objective is to evaluate the efficacy of MFNS in relieving the subject's symptoms of allergic rhinitis and asthma as measured by the Total 5 Symptoms Score (T5SS) and the Global Symptom Score (T5SS+asthma symptoms) and by the use of rescue medication on demand.
Ages Eligible for Study: | 18 Years to 75 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: | P05277 |
Study First Received: | January 10, 2008 |
Last Updated: | May 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00599027 History of Changes |
Health Authority: | Italy: Ethics Committee |
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Bronchial Diseases Mometasone furoate Asthma Quality of Life Rhinitis Anti-Allergic Agents |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Bronchial Diseases Immune System Diseases Mometasone furoate Asthma Rhinitis Anti-Allergic Agents Pharmacologic Actions |
Nose Diseases Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |