【medical-news】研究显示氟替卡松安特酰胺鼻腔喷雾治疗小儿变态反应性鼻炎有效且耐受良好
发布于 2007-03-01 · 浏览 1954 · IP 湖北湖北
这个帖子发布于 18 年零 67 天前，其中的信息可能已发生改变或有所发展。
Studies Showed Fluticasone Furoate Nasal Spray Was Well-Tolerated And Effective In Treating Allergic Rhinitis In Pediatric Patients
Main Category: Allergy News
Article Date: 28 Feb 2007 - 0:00 PST
Four out of every 10 children suffer from severe nasal allergy symptoms that may affect their overall well-being. Now, clinical research suggests that fluticasone furoate nasal spray (FFNS), a once-a-day allergy medicine under Food and Drug Administration review, effectively treats sneezing, runny nose, nasal itching, and nasal congestion in children 2 to 11 years of age with seasonal and year-round nasal allergies. Moreover, the investigational drug had no effect on children's short-term growth.
Data from these studies, including two Phase III trials (poster #1193, 1189) involving more than 1,100 children, were presented today at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). The Phase III studies were designed to evaluate how safe and effective FFNS was in children with either seasonal allergies, which are caused by pollen, or year-round allergies, which are caused by dust mites, mold, and animal dander. In both studies FFNS was found to be effective in reducing nasal symptoms, compared to placebo, and was generally well-tolerated.
In addition, researchers presented data from two studies (poster #1187, 909) that evaluated whether FFNS affected key safety measures in children, including short-term lower leg growth and a hormonal process known as hypothalamic-pituitary-adrenal (HPA) axis function. Both studies demonstrated that treatment with FFNS did not affect these important indicators of growth and hormonal function.
"Pediatricians and allergists who treat young children need options that will help them safely and effectively manage the symptoms of nasal allergies," said Eli Meltzer, M.D., co-director of the Allergy & Asthma Medical Group and Research Center in San Diego, Calif., who acted as lead investigator on one of the four pediatric studies that were presented at AAAAI. "These encouraging data suggest that FFNS could offer clinicians and parents a viable new treatment option for children with nasal allergies."
FFNS Effective and Well-Tolerated
In a study of 554 children 2 through 11 years of age with seasonal allergies, also known as SAR, researchers concluded that FFNS was effective in providing 24-hour relief from nasal allergy symptoms, including nasal congestion, sneezing, runny and itchy nose. The data showed statistically significant improvement in the primary and all key secondary efficacy endpoints in both the 6 to 11 age group (primary subset) and the entire population. For the primary endpoint, FFNS 110 mcg once-daily significantly reduced seasonal nasal symptoms compared with placebo (-3.16 for FFNS and -2.54 for placebo; p=0.025) for children ages 6 through 11. Similarly, significant improvement in nasal symptoms was reported for the entire study population treated with FFNS 110 mcg (-3.26 for FFNS and -2.65 for placebo; p=0.012). For both the primary subset and the entire population, FFNS demonstrated a 24-hour duration of action (-2.80 for FFNS and -2.13 placebo; p=0.015, and -2.87 for FFNS and -2.23 placebo; p=0.008, respectively). FFNS 55 mcg once-daily showed numerical reductions in the primary and key secondary endpoints, which were not significant when compared with placebo.
FFNS was well-tolerated and no drug-related serious adverse events were identified in this SAR study. The most common adverse event reported was headache, and the most common drug-related adverse event was nosebleed.
Another study compared the effects of long-term treatment with FFNS at 110 mcg and 55 mcg, versus placebo, of year-round allergies in 558 children ages 2 through 11. In this study, efficacy data were analyzed for a subset of patients 6 to 11 years of age. Overall, after four weeks' treatment, for the primary endpoint, study participants were evaluated for reductions in total nasal symptom scores for FFNS compared with placebo. FFNS 110 mcg once-daily showed numerical reductions in the primary endpoint, which were not significant when compared with placebo. FFNS 55 mcg once-daily, for the primary endpoint, significantly reduced year-round nasal symptoms compared with placebo (-4.16 for FFNS and -3.41 for placebo; p=0.003).
FFNS was well-tolerated and no drug-related serious adverse events were identified in this PAR study. The most common adverse events reported were throat pain, nosebleed, and fever.
Main Category: Allergy News
Article Date: 28 Feb 2007 - 0:00 PST
Four out of every 10 children suffer from severe nasal allergy symptoms that may affect their overall well-being. Now, clinical research suggests that fluticasone furoate nasal spray (FFNS), a once-a-day allergy medicine under Food and Drug Administration review, effectively treats sneezing, runny nose, nasal itching, and nasal congestion in children 2 to 11 years of age with seasonal and year-round nasal allergies. Moreover, the investigational drug had no effect on children's short-term growth.
Data from these studies, including two Phase III trials (poster #1193, 1189) involving more than 1,100 children, were presented today at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). The Phase III studies were designed to evaluate how safe and effective FFNS was in children with either seasonal allergies, which are caused by pollen, or year-round allergies, which are caused by dust mites, mold, and animal dander. In both studies FFNS was found to be effective in reducing nasal symptoms, compared to placebo, and was generally well-tolerated.
In addition, researchers presented data from two studies (poster #1187, 909) that evaluated whether FFNS affected key safety measures in children, including short-term lower leg growth and a hormonal process known as hypothalamic-pituitary-adrenal (HPA) axis function. Both studies demonstrated that treatment with FFNS did not affect these important indicators of growth and hormonal function.
"Pediatricians and allergists who treat young children need options that will help them safely and effectively manage the symptoms of nasal allergies," said Eli Meltzer, M.D., co-director of the Allergy & Asthma Medical Group and Research Center in San Diego, Calif., who acted as lead investigator on one of the four pediatric studies that were presented at AAAAI. "These encouraging data suggest that FFNS could offer clinicians and parents a viable new treatment option for children with nasal allergies."
FFNS Effective and Well-Tolerated
In a study of 554 children 2 through 11 years of age with seasonal allergies, also known as SAR, researchers concluded that FFNS was effective in providing 24-hour relief from nasal allergy symptoms, including nasal congestion, sneezing, runny and itchy nose. The data showed statistically significant improvement in the primary and all key secondary efficacy endpoints in both the 6 to 11 age group (primary subset) and the entire population. For the primary endpoint, FFNS 110 mcg once-daily significantly reduced seasonal nasal symptoms compared with placebo (-3.16 for FFNS and -2.54 for placebo; p=0.025) for children ages 6 through 11. Similarly, significant improvement in nasal symptoms was reported for the entire study population treated with FFNS 110 mcg (-3.26 for FFNS and -2.65 for placebo; p=0.012). For both the primary subset and the entire population, FFNS demonstrated a 24-hour duration of action (-2.80 for FFNS and -2.13 placebo; p=0.015, and -2.87 for FFNS and -2.23 placebo; p=0.008, respectively). FFNS 55 mcg once-daily showed numerical reductions in the primary and key secondary endpoints, which were not significant when compared with placebo.
FFNS was well-tolerated and no drug-related serious adverse events were identified in this SAR study. The most common adverse event reported was headache, and the most common drug-related adverse event was nosebleed.
Another study compared the effects of long-term treatment with FFNS at 110 mcg and 55 mcg, versus placebo, of year-round allergies in 558 children ages 2 through 11. In this study, efficacy data were analyzed for a subset of patients 6 to 11 years of age. Overall, after four weeks' treatment, for the primary endpoint, study participants were evaluated for reductions in total nasal symptom scores for FFNS compared with placebo. FFNS 110 mcg once-daily showed numerical reductions in the primary endpoint, which were not significant when compared with placebo. FFNS 55 mcg once-daily, for the primary endpoint, significantly reduced year-round nasal symptoms compared with placebo (-4.16 for FFNS and -3.41 for placebo; p=0.003).
FFNS was well-tolerated and no drug-related serious adverse events were identified in this PAR study. The most common adverse events reported were throat pain, nosebleed, and fever.
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