Safety of Once-Daily Ciclesonide Nasal Spray in Children 2 to 5 Years of Age with Perennial Allergic Rhinitis
| Autor: | Jerry Herron, Mark A. Wingertzahn, Paul H. Ratner, Nancy Hall, Michael Weiswasser, Ruediger Nave, Kenneth Kim, Anjuli Nayak |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Pulmonary and Respiratory Medicine
medicine.medical_specialty business.industry medicine.drug_class medicine.medical_treatment Ciclesonide Urine Placebo chemistry.chemical_compound chemistry Nasal spray Internal medicine Anesthesia Pediatrics Perinatology and Child Health Immunology and Allergy Medicine Corticosteroid Nasal administration business Adverse effect Active metabolite |
| Zdroj: | Pediatric Asthma, Allergy & Immunology. 20:229-242 |
| ISSN: | 1557-7767 0883-1874 |
| DOI: | 10.1089/pai.2007.002 |
| Popis: | Two double-blind studies in children aged 2 to 5 years with perennial allergic rhinitis (PAR) assessed the safety and efficacy of the intranasal corticosteroid ciclesonide. In the first study, 133 patients were randomized to once-daily ciclesonide 25, 100, or 200 μg or placebo for 6 weeks. In the second study, 125 patients were randomized to once-daily ciclesonide 200 μg or placebo for 12 weeks. Safety evaluations included adverse events, nasal examinations, and cortisol levels. Serum concentrations of ciclesonide and its pharmacologically active metabolite, desisobutyryl-ciclesonide (des-CIC), were measured at the end of the 6-week study. Efficacy evaluations included patient/caregiver-assessed 24-hour reflective total nasal symptom scores (TNSS), and physician-assessed nasal symptom scores (PNSS). Ciclesonide was well tolerated, demonstrating a safety profile comparable with placebo. Changes in plasma or urine cortisol levels in patients receiving ciclesonide ≤200 μg/day were not significantly different... |
| Databáze: | OpenAIRE |
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