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.

Decreased cortisol response to insulin induced hypoglycaemia in asthmatics treated with inhaled fluticasone propionate.

AIMS: To assess adrenal function in asthmatic children treated with inhaled fluticasone propionate for up to 16 weeks. METHODS: Children with asthma and bronchial hyperresponsiveness to inhaled methacholine were treated with inhaled fluticasone 250-750 microg/day via Volumatic spacer. The insulin tolerance test (ITT) was performed to assess adrenal function. RESULTS: Eighteen asthmatic patients (10 boys, 8 girls), aged 7-17 years received inhaled fluticasone therapy at a median dose of 477 microg/m2 per day for 5-16 weeks. Adrenal suppression, defined as 60 minute serum cortisol less than 500 nmol/l, was found in 9 of 18 children. Following the ITT, the median basal and 60 minute serum cortisol concentrations of the suppressed group were 135.0 and 350.0 nmol/l, respectively; the corresponding values for the unsuppressed group were 242.2 and 564.7 nmol/l. Repeat ITT in the suppressed group 2-3 months after discontinuation of fluticasone revealed that all patients had a 60 minute serum cortisol greater than 500 nmol/l. CONCLUSION: After therapy for asthma with inhaled fluticasone at approximately 500 microg daily for up to 16 weeks, half the children had evidence of adrenal suppression.

Fluticasone propionate and bronchial hyperresponsiveness in childhood asthma.

Bronchial asthma is now agreed as being a chronic inflammatory disease of the airways. Inhaled steroids are widely accepted as a preventive medication in asthmatic patients of all ages and severity. However, the optimal use of inhaled steroids and the important issue of safety and efficacy still remain of concern, particularly in children. Recently, fluticasone propionate (FP) has been developed for use as an inhaled preparation for the treatment of asthma. Because of its high topical potency and increased lipophilicity, it is claimed that FP has an improved risk/benefit compared with other inhaled steroids. In order to evaluate the use of FP in children, we have studied the efficacy of high dose FP (500 microg/day) in asthmatic children. Thirteen children (9 boys and 4 girls), aged 7-17 years (10.8 +/- 2.6), were instructed to use a pressurized metered-dose inhaler connected to a Volumetric spacer. The standard methacholine bronchial challenge test was used as a principal outcome parameter. The PD20, a cumulative dose of methacholine inducing a 20% decrease in FEV1, was measured pre- and post-treatment with inhaled FP. After 4 weeks of FP, PD20 significantly increased from 21.6 +/- 14.3 inhalation unit to 106.6 +/- 78.5 inhalation unit (4.9 fold, p = 0.004) reflecting the improvement of airway reactivity. All subjects improved clinically. These results demonstrate that the anti-inflammatory action of FP 500 microg a day for four weeks can markedly reduce bronchial hyperresponsiveness, the basic physiologic abnormality in bronchial asthma.

Peak expiratory flow rate values of students in Bangkok.

BACKGROUND: As there are considerable variations in normal values of peak expiratory flow rate (PEFR) shown by studies from various population, a study is required to obtain normal values of PEFR in Thai children. OBJECTIVE: To determine the values of PEFR of students in Bangkok. METHODS: In a cross sectional study of PEFR measured with standard Wright peak flow meter, 501 normal students, aged 5 to 15 years, from five public schools in Bangkok were investigated. In the selection process of subjects, strict criteria of "normality" were applied and included history of medical illnesses, physical examination and nutritional status. RESULTS: The relationship between PEFR and height was approximately linear in both male and female children. Prediction equations for each sex were: Male children: PEFR (L/min) = [3.52 x Height (cm)] - 186.80 Female children: PEFR (L/min) = [3.48 x Height (cm)] - 204.11 The PEFR values of students in this study were different from the predicted values of PEFR in those of previous reports in Thai children. These discrepancies might be explained by a variety of study population and environmental factors. CONCLUSIONS: The relationship between PEFR and height of students in Bangkok is best described by a regression equation. The prediction graphs for each sex may be used to monitor PEFR values of children with obstructive airway diseases and to compare an individual's PEFR with those of others of the same height and sex.

Incorrect use of metered dose inhaler by pediatric residents.

Currently press-and-breath metered dose inhalers (MDIs) are widely prescribed but are often difficult for many patients to properly use. However many medical personnel cannot use the MDIs correctly. We administered a question and observed usage of a placebo metered dose inhaler with ad-on spacer (Nebuhaler) among 127 second year pediatric residents. Forty-eight per cent of the residents performed at least six of nine steps correctly. The two most common errors made by participants were not to place mouthpiece tightly between teeth and lips (64%) and failure to breath out to functional residual capacity before actuation (55.3%). Of the residents with improper timing of actuation (49%) all actuated the canister before starting inhalation. (5 seconds or longer time). We conclude that (1) pediatricians should have additional instruction in proper MDIs usage and practice with the asthmatic child and (2) routine assessment of MDIs technique should be instituted as standard practice care.