Bronchodilating effects of a new beclometasone dipropionate plus formoterol fumarate formulation via pressurized metered-dose inhaler in asthmatic children: a double-blind, randomized, cross-over clinical study.

A new pediatric fixed combination of beclometasone dipropionate (BDP) 50 µg and formoterol fumarate (FF) 6 µg via pressurized metered-dose inhaler (pMDI) (CHF1535, Chiesi, Italy) was investigated. In a double-blind, randomized, placebo-controlled, cross-over study, a single CHF1535 administration using AeroChamber Plus™ spacer device (2 actuations, total dose BDP 100 µg/FF 12 µg) was compared to the same pMDI free combination in 56 asthmatic children aged ≥ 5 and < 12 years. Primary efficacy variable was forced expiratory volume during the first second (FEV1) area under the curve corrected by time over 12 h following morning dose (AUC0-12h). Further CHF1535 doses (50 µg/6 µg, 100 µg/12 µg, and 200 µg/24 µg) were also explored. Adverse events, electrocardiogram, and vital signs were monitored for safety. CHF1535 was non-inferior to free combination [adjusted mean difference (95% CI) 0.004 L (- 0.050, 0.041] with lower confidence limit greater than the limit set at 0.1 L. FEV1 AUC0-12h of each CHF1535 dose vs placebo were 0.037 L (p = 0.160), 0.119 L (p < 0.001), and 0.094 (p < 0.001) for 50/6, 100/12, and 200/24, respectively. No safety signals were found.Conclusion: CHF1535 was as effective as free combination BDP/FF, with a trend towards a dose-related response. All treatments were safe.Trial registration: ClinicalTrials.gov ID: NCT01584492 What is Known: •Inhaled pressurized metered-dose solutions (pMDI) are the preferred treatment for pediatric asthma. •Combination therapy of inhaled corticosteroids and long-acting ß2- agonists is a well-established approach to control airway inflammation and airway obstruction also in pediatric patients. What is New: •A novel pediatric pMDI fixed combination of beclomethasone dipropionate 50 µg and formoterol fumarate 6 µg (CHF 1535) was non-inferior to the free combination at the same dose in pulmonary function over the 12-h post-dose period in asthmatic children, with trend towards a dose-related response.

Efficacy and safety of immunotherapy for allergies to Alternaria alternata in children.

BACKGROUND: The safety and efficacy of specific immunotherapy for mold allergy are not known in children and adolescents. OBJECTIVE: We evaluated the efficacy and safety of specific immunotherapy with a standardized allergen extract in a randomized, double-blind, placebo-controlled, 3-year prospective study of patients who were allergic to only Alternaria alternata. METHODS: Fifty children and adolescents (25 girls; 5-18 years of age) with A alternata-induced seasonal allergic rhinoconjunctivitis and/or bronchial asthma were randomly assigned to groups given treatment (Novo-Helisen Depot, A alternata 100%) or placebo. The primary end point was the combined symptom medication score. Secondary end points included safety, quality of life, and sensitivity to allergen-specific nasal challenge. RESULTS: Forty-five children completed the 3-year study. Although there was no significant change in year 1, the combined symptom medication score decreased in years 2 and 3 of the study (by 38.7% and 63.5%, respectively; P < .001 for each). The reduction in symptoms was associated with a significant improvement in quality of life (P < .05) and decrease in sensitivity after allergen-specific nasal challenge. Side effects were observed in 7 patients; the most common (edema at the site of injection) occurred after 11 injections. CONCLUSIONS: Allergen-specific immunotherapy with standardized A alternata extract reduces symptoms of asthma and rhinoconjunctivitis in children and adolescents without serious side effects.

[Cockroach hypersensitivity in children suffering from perennial allergic rhinitis]. / Alergia na karalucha jako czynnik etiologiczny przewleklego niezytu nosa.

UNLABELLED: The role of cockroach allergens in the etiology of allergic disorders is still not clear. Published studies show a high variability in frequency of hypersensitivity to cockroaches. The aim of our work was to study the possible role of cockroach allergy in children suffering from perennial allergic rhinitis. MATERIAL AND METHODS: The study group consisted of 97 children with symptoms of perennial rhinitis admitted to our Outpatient Clinic. The data about medical history, symptoms, incomes and accomodation were gathered using a questionnaire. Skin prick tests (SPT) with a set of allergens including cockroaches were performed. RESULTS: Sixty boys and 37 girls with mean age 9.15 +/- 3.48 years, with mean duration of symptoms of perennial rhinitis 2.92 +/- 1.86 years were included it the study. In 28 children (28.9% of the study group) had all SPT negative. At least one positive SPT was found in 69% of patients. The most frequent allergens were house dust mites (Der f--65.2%, Der p--60.9%), followed by grasses (58%) and moulds (46.%). Positive SPT with cockroaches was found in 16 children (23.2%). The most frequent symptom in our study group was nasal congestion (68.4%). 46.4% of children complained about deterioration of nasal symptoms during a day. Perennial rhinitis coexisted with diagnosed bronchial asthma in 28 patients (28.9%) and with atopic dermatitis in 14 patients (14.4%). Presence of cockroaches at home was noticed in 3 cases and at school in 1 case. We did not find correlation between type of housing, living in a big city, small city or countryside and allergy to cockroaches (chi2 test p = 0.75). Hypersensitivity to cockroaches did not correlate with severity of rhinitis (U-Mann-Whitney test p = 1.0). There was no correlation between low incomes and allergy to cockroaches (chi2 test p = 0.294). CONCLUSIONS: The results of our study show that in our region hypersensitivity to cockroaches is one of possible, but not leading factor responsible for the development of perennial rhinitis.

Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study.

OBJECTIVE: To evaluate the efficacy and safety of three doses of ciclesonide (with or without spacer) in children with persistent asthma. PATIENTS AND METHODS: This was a multicentre, double-blind, placebo-controlled, 12-week study of ciclesonide 40, 80 or 160 µg (once daily pm). Children (6-11 years) were randomised 1:1 to treatment via a metered dose inhaler (MDI) or MDI plus spacer. The primary variable was change from baseline in mean morning peak expiratory flow (PEF). Secondary variables included: time to first lack of efficacy (LOE), asthma control, forced expiratory volume in 1 s (FEV(1)), asthma symptom score and quality of life (QoL). Safety assessments included: adverse events (AEs), urinary cortisol excretion and body height. RESULTS: In total, 1073 children received treatment. At endpoint, mean morning PEF significantly improved with all doses of ciclesonide vs. placebo. There was no difference over placebo in time to first LOE, but ciclesonide was superior to placebo on asthma control, symptom score, FEV(1) and QoL. There were no differences between the spacer or non-spacer subgroups. The incidences of AEs were comparable between treatment groups (approximately 35%) and there were no between-group differences in body height or urinary cortisol. CONCLUSIONS: Ciclesonide 40-160 µg once daily is effective and well tolerated in children with persistent asthma; its efficacy and safety are unaffected by the use of a spacer. clinicaltrials.gov registration number: NCT00384189.