Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar
| Autor: | Niran J. Amar, Frank C. Hampel, Bradley F. Marple, Michael J. Brubaker, Margaret Drake, G. Michael Wall, Julius H. van Bavel, Dale Mohar, Lewis H. Silver, Darell Turner, Peter S. Roland, Paul H. Ratner |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male Pulmonary and Respiratory Medicine Allergy Adolescent Nostril medicine.medical_treatment Immunology Placebo Administration Inhalation Anti-Allergic Agents otorhinolaryngologic diseases medicine Humans Immunology and Allergy Child Olopatadine Hydrochloride Nose Aged Demography Aged 80 and over Inhalation business.industry Rhinitis Allergic Seasonal Middle Aged Olopatadine medicine.disease Treatment Outcome medicine.anatomical_structure Nasal spray Juniperus Anesthesia Female business Dibenzoxepins medicine.drug |
| Zdroj: | Annals of Allergy, Asthma & Immunology. 95:474-479 |
| ISSN: | 1081-1206 |
| DOI: | 10.1016/s1081-1206(10)61174-x |
| Popis: | Background A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR) to mountain cedar. Objective To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo nasal spray in patients with SAR to mountain cedar. Methods This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 677 patients aged 12 to 81 years were randomized to receive 0.4% or 0.6% olopatadine or placebo, 2 sprays per nostril twice daily for 2 weeks. Patients evaluated morning and evening reflective and instantaneous nasal symptoms (sneezing, stuffy nose, runny nose, and itchy nose, which compose the total nasal symptom score [TNSS]) and ocular symptoms. Results Olopatadine spray (0.4% and 0.6%) was statistically significantly superior to placebo for percentage change from baseline in overall reflective and instantaneous TNSSs. Also, 0.6% olopatadine was statistically significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny nose, itchy nose, stuffy nose, itchy eyes, and watery eyes. Olopatadine spray exhibited a safety profile comparable with that of placebo. Conclusions Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs and individual symptoms, including congestion, itchy and runny nose, sneezing, and itchy and watery eyes, in patients with SAR to mountain cedar. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults. |
| Databáze: | OpenAIRE |
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