The efficacy and safety of 30 mg fexofenadine HCl bid in pediatric patients with allergic rhinitis.

Allergic rhinitis is one of the most common chronic disorders in children. It is also one of the most common causes of absence from school. This study reports on the efficacy and safety of a twice-daily oral dose of fexofenadine HCl 30 mg in Asian children aged 6-11 years diagnosed with seasonal or perennial allergic rhinitis. A total of 100 children with a history of allergic rhinitis for more than one year and a positive prick skin test response to at least one of the common aeroallergens in Thailand were enrolled in this multi-center, open-label, non comparative study. The severity of individual symptoms such as sneezing, rhinitis, etc. and adverse events were recorded in diary cards by the patients in form of scores as well as by the investigator at each visit. The total symptom score (TSS) with or without blocked nose at baseline, week 1 and week 2 was recorded. The TSS was defined as the sum of the individual symptom scores except for the nasal blockage score, as nasal blockage was not expected to respond to antihistamine treatment. Only patients with a total symptom score > or = 6 were included in the study. There was a statistically significant improvement at p < 0.01 for the TSS with or without blocked nose and for each symptom score such as blocked nose, sneezing, rhinorrhea, itchy nose/palate and/or throat, and itchy/watery/red eyes from baseline to week 1 and week 2. Additionally, there was a statistically significant improvement between week 1 and week 2 for itchy nose/palate and/or throat and itchy/watery/red eyes (p < 0.05). The Kappa measure of agreement was statistically significant at p < 0.001 between investigator's and patient's/parent's assessment, indicating the same degree of satisfaction with the overall effectiveness of the treatment. Fexofenadine 30 mg bid is effective in reducing the total symptom score of allergic rhinitis including blocked nose and is generally well tolerated. It is not cardiotoxic and is safe for pediatric patients as young as 6 years of age.

Serum IgG subclass levels in a group of healthy Thai children.

Gammaglobulins are the major components of the humoral immune response to foreign antigens. Yet, they may cause disease, for example, in certain malignancies or autoimmune disorders. The discovery of IgG subclasses, IgG1-IgG4, has further led to the realization that various gammaglobulin deficiencies may be ascribed to IgG subclass abnormalities. In order to establish a set of reference values in Thai children we have determined the range of total IgG and IgG subclass levels among a cohort of 195 healthy Thai children chosen semi-randomly from those at the Well Child Clinic, Chulalongkorn Hospital, who fitted certain inclusion criteria such as absence of recent infection or history of recurrent infections. The sera obtained were subjected to a laboratory test performed by means of a commercially available kit which uses the radial immunodiffusion technique for distinguishing the different IgG subclasses. The results obtained showed the total immunoglobulin increasing with age, as well as subclasses IgG1, IgG2 and IgG4, whereas subclass IgG3 remained at an almost constant level, irrespective of the age group tested.

Fluticasone propionate aqueous nasal spray treatment for perennial allergic rhinitis in children.

BACKGROUND: Topical corticosteroid is now accepted as safe and most effective in controlling all symptoms of both allergic and nonallergic rhinitis. Fluticasone propionate aqueous nasal spray is a new once daily topical corticosteroid preparation. OBJECTIVE: To evaluate the efficacy and safety of fluticasone propionate in children 5 to 11 years of age with perennial allergic rhinitis. METHOD: A double-blind, placebo-controlled, parallel group of 127 recruited patients of whom 106 were evaluated. Treatment with once daily fluticasone propionate 100 micrograms or placebo for 4 weeks followed by a 2-week followup period. Fifty-three patients of each group were treated with fluticasone propionate or placebo by randomized assignment. RESULTS: There was no statistical significance of the sex, mean age, weight, and height of the two groups. Patients treated with fluticasone propionate showed a significant decrease in total symptom scores rated by physicians at 2 weeks and 4 weeks, respectively (P < .01, P < .05). The rhinitis symptom scores in treatment group rated by patients (nasal blockage, sneezing, rhinorrhea) were significantly decreased at 2 weeks (P < .05, P < .01). Nasal symptoms as assessed by doctors (turbinate swelling, color of nasal mucosa, secretion, and postnasal drip) also decreased at 2 and 4 weeks, but were not statistically significant, except for the secretion at 2 weeks and postnasal drip at 4 weeks (P < .05). There was no evidence of effects on adrenal function by morning plasma cortisol concentration between the two groups. CONCLUSION: Fluticasone propionate was safe and effective in children aged 5 to 11 years with perennial allergic rhinitis.

Indirect enzyme-linked immunosorbent assay for measurement of human immunoglobulins E and G to purified cow's milk proteins: application in diagnosis of cow's milk allergy.

An indirect double-antibody enzyme-linked immunosorbent assay (ELISA) was developed for the measurement of human immunoglobulin E (IgE) and IgG to the cow's milk proteins (CMP) alpha-casein, alpha-lactalbumin, and beta-lactoglobulin. Human serum albumin was used as the negative-antigen control. Rabbit anti-human IgE or IgG served as the primary antibody, and horseradish peroxidase-conjugated swine anti-rabbit immunoglobulin served as the secondary antibody. Positive control sera were obtained from patients with well-documented histories of cow's milk allergy, while negative control sera were obtained from cord bloods of healthy full-term infants and from normal adult volunteers without known milk allergy. Test sera were obtained from 41 children (ages, 3 months to 13 years; average age, 2.6 years) with suspected cow's milk allergy and clinical manifestations that included wheezing, rhinitis, atopic dermatitis, urticaria, or gastrointestinal disturbances. The patients were simultaneously evaluated by prick skin testing with scratch test antigen to whole CMP. Although only 13 (32%) of the 41 patients were positive by the prick skin test, 25 (61%) were positive by the IgE ELISA. Of the 25 IgE ELISA-positive patients, 20 were also positive by the IgG ELISA. There was concordance of positive results between skin testing and the IgE ELISA in only 9 patients (22%), and there was concordance of negative results in 12 patients (29%). Discordant results were observed in 20 patients (49%). These results indicate that the ELISA is more sensitive than prick skin testing in the identification of individuals with elevated levels of IgE to CMP.