American journal of rhinology & allergy · 2013
Therapeutic equivalence of triamcinolone acetonide hydrofluoroalkane and chlorofluorocarbon nasal inhalers in patients with seasonal allergic rhinitis.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Schenkel Eric, Newman Kenneth B
Аннотация
BACKGROUND: Triamcinolone acetonide (TAA) has been reformulated as an hydrofluoroalkane (HFA) aerosol for intranasal use in patients with seasonal allergic rhinitis (SAR). This study compared the TAA HFA formulation with the previously available chlorofluorocarbon (CFC) nasal inhaler in a dose-ranging study.
METHODS: This was a double-blind, parallel-group, multicenter study in 780 adults with SAR. Patients had a history of fall seasonal rhinitis and positive skin tests to ragweed. After meeting minimum symptom requirements during the run-in phase, patients were randomized to one of eight groups: TAA CFC or HFA at 14, 110, or 440 micrograms once daily or matching placebo. Treatment was continued for two weeks and patient completed a daily diary for reflective and instantaneous rating of nasal and ocular allergy symptoms.
RESULTS: All active treatment groups were statistically superior to placebo with respect to the primary outcome variable, total nasal symptoms. Furthermore, the TAA HFA and TAA CFC formulations were statistically comparable over the dose range. Within each formulation, there was a significant mean reduction from baseline in the symptoms of rhinitis that increased with increasing dose. Ocular symptoms were also reduced with both formulations. Both preparations were well tolerated without any safety concerns.
CONCLUSION: In conclusion, a new formulation of TAA with a HFA propellant was found to be effective in the treatment of SAR and comparable with the previously available TAA CFC formulation. There was a dose response to TAA, with doses as low as 7 micrograms per nostril once daily producing statistically significant improvement in rhinitis symptoms.
METHODS: This was a double-blind, parallel-group, multicenter study in 780 adults with SAR. Patients had a history of fall seasonal rhinitis and positive skin tests to ragweed. After meeting minimum symptom requirements during the run-in phase, patients were randomized to one of eight groups: TAA CFC or HFA at 14, 110, or 440 micrograms once daily or matching placebo. Treatment was continued for two weeks and patient completed a daily diary for reflective and instantaneous rating of nasal and ocular allergy symptoms.
RESULTS: All active treatment groups were statistically superior to placebo with respect to the primary outcome variable, total nasal symptoms. Furthermore, the TAA HFA and TAA CFC formulations were statistically comparable over the dose range. Within each formulation, there was a significant mean reduction from baseline in the symptoms of rhinitis that increased with increasing dose. Ocular symptoms were also reduced with both formulations. Both preparations were well tolerated without any safety concerns.
CONCLUSION: In conclusion, a new formulation of TAA with a HFA propellant was found to be effective in the treatment of SAR and comparable with the previously available TAA CFC formulation. There was a dose response to TAA, with doses as low as 7 micrograms per nostril once daily producing statistically significant improvement in rhinitis symptoms.