Bronchodilator responsiveness using spirometry in healthy and asthmatic preschool children.

OBJECTIVE: To assess repeatability and reproducibility of spirometry measurements, and bronchodilator responsiveness (BDR), in healthy 3-6-year-old preschool children and those with asthma. DESIGN: Spirometry was performed before and 20 minutes after administering either inhaled placebo (for repeatability) or 400 µg salbutamol (for BDR) on two separate occasions (reproducibility) 3-23 days apart in asthmatic preschoolers and healthy controls. SETTINGS: Lung Function Laboratory, Hospital de Dona Estefania, Lisbon. PARTICIPANTS: Healthy preschool children and those with physician-diagnosed asthma, recruited from local Health Clinics and Outpatient Clinic. MAIN OUTCOME MEASURES: Paired measurements of forced expired volume in 0.75 s (FEV(0.75)) and forced mid-expiratory flows (FEF(25-75)). RESULTS: Technically successful baseline results were obtained in 86% of children assessed. Paired data were obtained in 43 asthmatic and 22 controls (median (range) age: 5.1 (3.4-6.8) years). Baseline FEV(0.75) was significantly lower in asthmatic children (mean (SD): 90 (15)% predicted) than in controls (102 (13) % predicted; p<0.001). Within-occasion coefficient of repeatability following placebo was similar in both groups, being 10.4% in asthma and 13.2% in controls for FEV(0.75). Following bronchodilator, FEV(0.75) increased significantly more in asthmatic preschoolers (mean (SD): 15.0 (12) %) than in controls (4.5 (5) %; p<0.001), with no significant difference between groups post-bronchodilator. Between-occasion variability was similar to within-day repeatability in controls, but almost twice as high in asthmatic children. CONCLUSIONS: BDR can be assessed reliably using FEV(0.75) in wheezy preschoolers, provided within-subject variability and responsiveness in health are taken into consideration.

Safety and efficacy of oral fexofenadine in children with seasonal allergic rhinitis--a pooled analysis of three studies.

Allergic rhinitis is one of the most common clinical conditions in children; however, data regarding the safety of antihistamines in children with seasonal allergic rhinitis are limiting. To evaluate the safety and efficacy of fexofenadine in children with seasonal allergic rhinitis, data were pooled from three, double-blind, randomized, placebo-controlled, parallel-group, 2-week trials in children (6-11 year) with seasonal allergic rhinitis. All studies assessed fexofenadine HCl 30 mg b.i.d.; two studies included fexofenadine HCl at 15 and 60 mg b.i.d. Patients (and investigators) reported any adverse events during the trial. Physical examinations, including measurements of vital signs and laboratory tests, were performed. Efficacy assessments (total symptom score and individual symptom scores) were evaluated. Exposure to fexofenadine HCl 30 mg b.i.d. and to any fexofenadine dose exceeded 10,000 and 17,000 patient days, respectively. Incidences of adverse events, and discontinuations because of adverse events, were low and similar across treatment groups. In the placebo group, 24.4% of subjects reported adverse events compared with 24.1% for fexofenadine HCl 30 mg b.i.d., and 28.4% for all fexofenadine-treated groups. The most common adverse event overall was headache (4.3% placebo; 5.8% fexofenadine HCl 30 mg b.i.d.; and 7.2% any fexofenadine doses). Treatment-related adverse events were similar across treatment groups with no sedative effects. Fexofenadine HCl 30 mg b.i.d. was significantly superior to placebo in reducing the total symptom score and all individual seasonal allergic rhinitis symptoms, including nasal congestion (p < 0.05). Fexofenadine, at doses of up to 60 mg b.i.d., is safe and non-sedating, and fexofenadine HCl 30 mg b.i.d. effectively reduces all seasonal allergic rhinitis symptoms in children aged 6-11 years.

Fexofenadine is efficacious and safe in children (aged 6-11 years) with seasonal allergic rhinitis.

BACKGROUND: This is the first prospective, randomized, double-blind, placebo-controlled study showing statistical improvement of an H(1)-antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period. OBJECTIVE: This randomized, placebo-controlled, parallel-group, double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis. METHODS: This study was conducted at 148 centers in 15 countries. Nine hundred thirty-five children (aged 6-11 years) were randomized and treated with either fexofenadine HCl 30 mg (n = 464) or placebo (n = 471) tablets twice a day for 14 days. Individual symptoms (sneezing; rhinorrhea; itchy nose, mouth, throat, and/or ears; itchy, watery, and/or red eyes; and nasal congestion) were assessed at baseline and then daily at 7:00 AM and 7:00 PM (+/-1 hour) during the double-blind treatment period. Each total symptom score was the sum of all symptoms, excluding nasal congestion. The primary efficacy variable was the change from baseline in the average of the daily 12-hour evening reflective total symptom scores throughout the double-blind treatment. Safety was evaluated from adverse-event reporting, vital signs, physical examinations, and clinical laboratory data at screening and study end point. RESULTS: Fexofenadine was significantly superior to placebo in the primary efficacy analysis (P

Risk factors for asthma admissions in children.

Bronchial asthma is related to a high morbidity rate, leading to an increasing frequency of emergency room visits and hospital admissions. The aim of this study was to identify severity risk factors for childhood asthma related to hospitalization. The authors studied 124 children admitted to the hospital for asthma, during a 2-year period, correlating the obtained data with a sample of outpatients with asthma matched by age, gender, and socioeconomic status. A standardized questionnaire and skin-prick tests (SPTs) were performed on all children. The significant and independent risk factors identified for hospital admission were prior asthma hospitalization (OR = 7.63; 95% CI = 1.5-39.6; p = 0.01) and last-year admission (OR = 3.18; 95% CI = 1.1-8.9; p = 0.02), environmental tobacco-smoke exposure (OR = 6.63; 95% CI = 2.5-17.8; p = 0.002), allergen sensitization (OR = 3.86; 95% CI = 1.4-10.7; p = 0.009), family history of maternal asthma (OR = 3.58; 95% CI = 1.3-9.6; p = 0.01), and onset of symptoms before 12 months of age (OR = 2.76; 95% CI = 1.0-7.9; p = 0.06). Attendance at day care or kindergarten (OR = 0.38; 95% CI = 0.2-0.9; p = 0.04) and large family size (OR = 0.25; 95% CI = 0.1-0.8; p = 0.01) could be protective factors. Our results stress the importance of early diagnosis and specialized medical care of childhood asthma, mainly in high-risk children, with emphasis on medication planning and the establishment of preventive measures such as environmental tobacco smoke avoidance and limitation of aeroallergen exposure.