Budesonide/formoterol maintenance and reliever therapy versus conventional best standard treatment in asthma in an attempted 'real life' setting.

AIMS: The purpose of this study was to compare the efficacy of budesonide/formoterol maintenance and reliever therapy (Symbicort® SMART®, AstraZeneca AB, Södertälje, Sweden) with conventional best standard treatment (CBST) in patients with persistent asthma in an attempted 'real life' setting. METHODS: In total, 1835 patients from Denmark, Finland and Norway were randomized to 26 weeks treatment with budesonide/formoterol 160/4,5 µg twice daily plus budesonide/formoterol 160/4,5 µg for symptom relief or CBST according to the Global Initiative for Asthma guidelines. The study was randomized, open-label and designed to reflect 'real life' asthma management. Efficacy variables were time to first severe asthma exacerbation, rate of severe asthma exacerbations, asthma control (Asthma Control Questionnaire-5) and use of inhaled glucocorticosteroids (IGCS). RESULTS: Treatment with budesonide/formoterol maintenance and reliever therapy led to a 21% reduction in time to first severe asthma exacerbation compared with CBST, although not statistically significant (hazard ratio 0.794, P = 0.189). A trend towards a reduction in the rate of severe exacerbations in the budesonide/formoterol maintenance and reliever therapy group was observed (16 vs 22 events/100 patient years; P = 0.058). The percentage of patients with well-controlled asthma increased significantly among those treated with budesonide/formoterol maintenance and reliever therapy compared with CBST (45% vs 40%; odds ratio 1.39; P < 0.01), in spite of a significant 31% reduction in total mean daily IGCS dose (P < 0.0001). No difference in mean as-needed medication use was seen (P = 0.98). All treatments were well tolerated. CONCLUSION: Budesonide/formoterol maintenance and reliever therapy resulted in a better overall asthma control with a significant lower daily IGCS dose compared with CBST.

Thirteen-year follow-up of early intervention with an inhaled corticosteroid in patients with asthma.

BACKGROUND: In a 3-year study, adult patients who recently developed asthma (symptoms for less than 1 year) were treated for 2 years with the inhaled corticosteroid (ICS) budesonide (early therapy) or terbutaline. During the third year of the study, terbutaline-treated patients received budesonide (delayed therapy). Differences in lung function and bronchial responsiveness to histamine were observed between the 2 groups. OBJECTIVE: We compared the effects of early versus delayed budesonide therapy after a 10-year follow-up period (13 years after the study began) and current real-life data. METHODS: Of the original 103 patients, 90 were re-examined 13 years after study initiation. After the third year of the study, all patients had their medications, including the dose of ICS, individually adjusted. RESULTS: After the follow-up period, lung function was within the normal range for the entire group (all patients); bronchial responsiveness significantly improved compared with baseline data. No statistically significant differences in clinical or functional variables were found between patients given early or delayed budesonide therapy. However, the delayed therapy group had a higher neutrophil count and higher concentrations of eosinophilic cationic protein and myeloperoxidase in induced sputum. This group had also used more asthma medication and hospital days. CONCLUSIONS: Patients with relatively mild asthma who received ICS within 12 months of their first asthma symptoms or after a 2-year delay achieved equally good functional control of asthma after 10 years of individualized therapy. However, the delayed therapy group exhibited slightly less optimal disease control and more signs of airway inflammation.

Salmeterol resolves airway obstruction but does not possess anti-eosinophil efficacy in newly diagnosed asthma: a randomized, double-blind, parallel group biopsy study comparing the effects of salmeterol, fluticasone propionate, and disodium cromoglycate.

BACKGROUND: Salmeterol (SLM) is a long-acting beta(2)-receptor agonist that produces bronchodilatation for 12 hours in asthmatic subjects. The effects of the regular use of long-acting beta(2)-agonists on airway inflammation are largely unknown. OBJECTIVES: We examined the effects of 16 weeks of treatment with 50 microg SLM bid, 250 microg fluticasone propionate (FP) bid,5 mg disodium cromoglycate (DSCG) qid, or placebo on airway inflammation in bronchial mucosa. METHODS: Airway inflammation was assessed in bronchial biopsy specimens before and after treatments and bronchial hyperresponsiveness (BHR) in 80 patients with newly diagnosed asthma. Inflammatory cells and tenascin in the basement membrane were studied with immunohistochemical methods. Peak expiratory flow rate (PEF), symptoms, and need for rescue medication were recorded. RESULTS: SLM, FP, and DSCG reduced symptoms and need for rescue medication (P <.04). Both SLM and FP improved PEF and increased PD15FEV(1) to histamine by 2.8 and 5.2 doubling dose units, respectively. Both compounds reduced BHR more than placebo (P <.05). Both SLM and placebo had no effect on any inflammatory cell type. In both FP-treated and DSCG-treated patients, the number of EG2-positive eosinophils in the airway mucosa decreased (P =.002 and P <.05, respectively). CONCLUSIONS: SLM showed no anti-eosinophil properties in this study, but it provided good symptom control. FP provided the best anti-eosinophil properties and symptom relief of the studied compounds.