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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 History of Changes |
Health Authority: | Italy: Ministry of Health |
Neurotransmitter Agents Otorhinolaryngologic Diseases Cholinergic Antagonists Bronchial Diseases Asthma Rhinitis Anti-Allergic Agents Cholinergic Agents Desloratadine Histamine Lung Diseases, Obstructive Hypersensitivity |
Histamine Antagonists Loratadine Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Lung Diseases Hypersensitivity, Immediate Antipruritics Histamine phosphate Histamine H1 Antagonists Respiratory Hypersensitivity |
Neurotransmitter Agents Bronchial Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Rhinitis Cholinergic Agents Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Loratadine Therapeutic Uses Antipruritics Dermatologic Agents |
Otorhinolaryngologic Diseases Immune System Diseases Histamine Agents Asthma Anti-Allergic Agents Desloratadine Nose Diseases Pharmacologic Actions Histamine Antagonists Lung Diseases Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Respiratory Hypersensitivity |