Budesonide/formoterol single inhaler therapy has the potential to provide a complete asthma management approach with one inhaler, demonstrating a high level of efficacy in patients with moderate to severe asthma.

No abstract

The aim of this study was to compare the clinical efficacy of low-dose inhaled budesonide (once or twice daily) and placebo, administered via Turbuhaler, on exercise-induced bronchoconstriction (EIB) in children with mild asthma. Fifty-seven steroid-naive children (7-16 years old; 41 boys, 16 girls) with EIB participated in this sub-population study according to the following inclusion criterion: a maximum fall in forced expiratory volume in 1 s (FEV1) > or = 10% after a standardized treadmill test. Mean baseline FEV1 was 100.3% of predicted, and mean maximum fall in FEV1 after the standardized exercise test was 22%. The study was a double-blind, randomized, parallel-group design. After 2 weeks of run-in, the children received inhaled budesonide 100 microg or 200 microg once daily in the morning, 100 microg twice daily, or placebo, for 12 weeks. After 12 weeks of treatment, the fall in FEV1 after the exercise test was significantly less in all three budesonide groups (7.2-7.8%) vs. placebo (16.7%). Daytime symptom scores were significantly lower in all three budesonide groups compared with placebo (p <0.02). The three budesonide groups did not differ significantly, and no significant change in lung function was found in any group. Therefore children with mild asthma, but with significant EIB, improved their exercise tolerance and symptom control after 3 months of treatment with a low dose of inhaled budesonide given once or twice daily.

Once-daily budesonide is effective and well tolerated as initial treatment for adults and children with mild asthma and as maintenance therapy in patients with more severe asthma once asthma control has been achieved.

69 Caucasian children, 34 with non-atopic and 35 with atopic bronchial asthma, demonstrated different, Gm-associated IgG antibody responsiveness. The non-atopic bronchial asthma group showed a preponderance of the Gm(aXXXg) haplotype, while the atopic study group showed a preponderance of the haplo-type with the alternative allotypes on all IgG subclass loci, namely Gm(fnb). Patients with non-atopic bronchial asthma showed a significantly increased frequency of the phenotypes containing the Gm(aXXXg) haplotype, namely the Gm(aXXXg/aXXXg) and Gm(aXXXg/fXXXb), and an increased number of individuals were homozygous G2m(XXX,XXX) on the IgG2 locus. The 2 asthma groups showed different characteristic IgG subclass patterns, the non-atopic group with significantly decreased IgG2 and IgG3, especially those of the Gm(aXXXg/aXXXg) phenotype, and the atopic group with significantly increased IgG1 and IgG4, especially those of the Gm(fnb/fnb) phenotype. The characteristic IgG subclass patterns originate from the different Gm phenotypes found in the 2 groups. The results emphasize the presence of qualitatively and quantitatively different IgG molecules in non-atopic and atopic bronchial asthma patients and show the interest in studying IgG genes and IgG molecules as markers of pathogenesis. G2m(XXX,XXX) homozygosity is a new important marker of non-atopic bronchial asthma.

Seven asthmatic children were given terbutaline intravenously. The intact drug was measured in plasma and urine, and its conjugates were measured in urine. The decreasing plasma concentrations of terbutaline did not attain a terminal slope until 8-12 h after dosing. This was most likely due to different kinetics of the enantiomers. The terminal half-life was 8.8-15.8 h. Body clearance was 2.73-5.44 ml/min/kg, two-thirds of which were of renal origin. The volume of distribution (V(ss)) was 1.28-1.83 l/kg. The disposition pharmacokinetics of terbutaline do not rationalize a higher dose per kg body weight in children than in adults.

A search for IgE antibodies was performed in 224 children, aged 0–15 yr, with symptoms compatible with IgE‐mediated allergy, employing total IgE. RAST with up to 17 allergens and the Phadiatop® test. Fiftysix of 113 children (50%), aged 0–3 yr, and 80 of 111 children (72%) aged 4–15 yr had specific IgE antibodies. The most common allergens during the first 4 yr were egg white, a mixture of nuts (hazel nut, peanut, almond, coconut and Brazil nut) and milk. During the 2nd yr of life inhalant allergens became more important. From the 3rd yr they became more common than food allergens as sensitizers. Among the children aged 4–15 yr timothy, cat and nut mix were the most common allergens. Among the children with specific IgE antibodies Phadiatop was positive in 58% of the children younger than 4 yr, and in 91% of the children over that age. Fifty‐three of the children with IgE antibodies against nut mix were further investigated for antibodies against hazel nut, peanut and almond, and 48 (91%) were positive against at least one of them. The parents of 41 of these patients answered a questionnaire about adverse symptoms against nuts, and 26 (63%) were aware of clinical sensitivity. In conclusion, IgE antibodies against food allergens dominated in children under 2 yr, and thereafter antibodies against inhalants became more important. An unexpectedly high prevalence of IgE antibodies against nut mixture was found. Phadiatop was a good screening method for identification of children 4 yr or older with IgE antibodies against inhalants.

Turbuhaler is a ready-loaded multiple dose inhaler which does not require co-ordination between release of dose and inhalation. 57 children with asthma participated in this clinical trial to compare the clinical effect and acceptance of terbutaline sulphate via Turbuhaler with that of metered dose inhaler (MDI). The trial consisted of two parts. In the first part of the study, which made use of a double-blind cross-over design, the clinical effect and number of treatment occasions with Turbuhaler were compared with those of MDI. In the second part, which was open, all patients were treated with Turbuhaler for 2 weeks. At the end of this period the patients were asked to make a subjective assessment of effect and to state their preference. There was no difference in clinical effect and number of treatment occasions between Turbuhaler and MDI. A majority of the patients thought Turbuhaler had the best effect and was easy to use.