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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00805324 |
The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The doctor also rated how much relief the patient got from treatment and recorded any side effects.
Condition | Intervention | Phase |
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Rhinitis, Allergic, Seasonal Asthma |
Drug: Desloratadine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Efficacy and Safety of Desloratadine Syrup in Children Suffering From Seasonal Allergic Rhinitis With or Without Intermittent Asthma |
Enrollment: | 54 |
Study Start Date: | May 2003 |
Study Completion Date: | August 2003 |
Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: Desloratadine
desloratadine syrup; 5.0 mL once daily for 28 days
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Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by:
Exclusion Criteria:
Children who have not observed the designated washout periods for any of the prohibited medications
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P03472 |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00805324 |
Health Authority: | Italy: Ministry of Health |
Otorhinolaryngologic Diseases Asthma Rhinitis Desloratadine Histamine Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases |
Respiratory Tract Infections Loratadine Rhinitis, Allergic, Seasonal Lung Diseases Hypersensitivity, Immediate Histamine phosphate Respiratory Hypersensitivity |
Neurotransmitter Agents Bronchial Diseases Immune System Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Anti-Allergic Agents Cholinergic Agents |
Nose Diseases Pharmacologic Actions Histamine Antagonists Therapeutic Uses Antipruritics Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Dermatologic Agents |