pulmicort and 3-(2-(4-azidobenzamidino)ethyl)-5-hydroxyindole

This non-interventional real-life study (NCT00884689) compared budesonide/formoterol (Symbicort®) maintenance and reliever therapy (SMART™) with a free combination of inhaled corticosteroid (ICS) + long-acting β2-agonist (LABA) (in separate inhalers) and as-needed short-acting β2-agonist (SABA) in adult asthma patients with an exacerbation in the past 24 months.. Asthma patients received SMART™ or free-combination ICS + LABA and as-needed SABA for 6 months. Allocation of patients and doses prescribed were at physician's discretion. No other restrictions applied. Primary endpoint: mean no. of rescue medication puffs/day.. 482 patients were included (SMART™ n = 310; free combination n = 172). SMART™ patients used less rescue medication vs the free-combination group (mean difference - 0.27 puffs/day; p = 0.013). Severe asthma exacerbations were rare (mean rate 0.20 vs 0.17/year for SMART™ vs free combination). The mean ICS dose was 615 µg in SMART™ and 678 µg in free-combination group.. In this real-life setting, SMART™-treated patients used less rescue medication despite a lower ICS burden vs conventional asthma management with three different inhalers.

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Azides; Budesonide; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Germany; Humans; Male; Middle Aged; Prevalence; Quality of Life; Risk Factors; Self Administration; Serotonin; Treatment Outcome

Budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) improves asthma control compared with fixed-dose inhaled corticosteroid/long-acting beta(2)-agonist (ICS/LABA) regimens, but its efficacy has not been assessed in comparison with sustained high-dose salmeterol/fluticasone (Seretide) plus a short-acting beta(2)-agonist (SABA).. Patients (N=2309) with symptomatic asthma (aged 12 years; forced expiratory volume in 1s 50% predicted), who had experienced an asthma exacerbation in the previous year, were randomised to receive budesonide/formoterol 160/4.5 microg two inhalations twice daily and as needed, or one inhalation of salmeterol/fluticasone 50/500 microg twice daily plus terbutaline as needed, for 6 months.. Time to first severe exacerbation, the pre-specified primary outcome, was not significantly prolonged (risk ratio 0.82; 95% confidence interval 0.63, 1.05). Budesonide/formoterol maintenance and reliever therapy reduced total exacerbations from 31 to 25 events/100 patients/year (P=0.039), and exacerbations requiring hospitalisation/emergency room (ER) treatment from 13 to 9 events/100 patients/year (P=0.046). The treatments showed no difference in measures of lung function or asthma symptoms. The mean dose of ICS received was lower using budesonide/formoterol maintenance and reliever therapy (792 microg/day budesonide [1238 microg/day beclomethasone dipropionate (BDP) equivalent] versus 1000 microg/day fluticasone [2000 microg/day BDP equivalent] with salmeterol/fluticasone therapy; P<0.0001). Both treatments were well tolerated.. In the treatment of uncontrolled asthma, budesonide/formoterol maintenance and reliever therapy reduces the incidence of severe asthma exacerbations and hospitalisation/ER treatment with similar daily symptom control compared with sustained high-dose salmeterol/fluticasone plus SABA. This benefit is achieved with substantially less ICS exposure.

Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Azides; Budesonide; Child; Chronic Disease; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Ethanolamines; Female; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Hospitalization; Humans; Lung; Male; Middle Aged; Proportional Hazards Models; Respiratory Function Tests; Serotonin; Treatment Outcome