title: The safety and efficacy of formoterol (Oxis) turbuhaler plus budesonide (Pulmicort) turbuhaler in mild to moderate asthma: a comparison with budesonide Turbuhaler alone and current non-corticosteroid therapy in Russia.
abstract: Current therapy in Russia for long-term management of asthma is mainly non-steroidal. This provided the opportunity to compare the efficacy and safety of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone in adults (n=338) with mild to moderate asthma who had little previous exposure to inhaled corticosteroids. The 12-week study followed a randomised, double-blind, parallel group design and included an open control group of patients who were treated with conventional non-corticosteroid therapy. Patients treated with formoterol plus budesonide benefited from a significantly greater improvement in their pulmonary function and asthma symptoms compared with budesonide alone (95% Cl of difference in mean morning peak expiratory flow [PEF] 8.7-36.3 l/min, p=0.0015). Non-corticosteroid treatment was significantly less effective than formoterol plus budesonide and budesonide alone (95% CIs of differences in mean morning PEF were 36.4-63.6 l/min and 14.1-41.1 l/min, respectively, both p=0.0001). Although the incidence and frequency of adverse events was not significantly different between the groups, formoterol plus budesonide and budesonide alone were better tolerated than non-corticosteroid treatment, and there were fewer incidences of asthma deterioration. Overall, formoterol Turbuhaler plus budesonide Turbuhaler was the safest and most effective treatment.
authors.affiliation: Russian Research Institute of Pulmonology, Moscow.
authors.forename: A G
authors.initials: AG
authors.lastname: Chuchalin
authors.forename: S I
authors.initials: SI
authors.lastname: Ovcharenko
authors.forename: L A
authors.initials: LA
authors.lastname: Goriachkina
authors.forename: I V
authors.initials: IV
authors.lastname: Sidorenko
authors.forename: A N
authors.initials: AN
authors.lastname: Tsoi
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000627:therapeutic use*; D004311:Double-Blind Method; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D005541:Forced Expiratory Volume / Q000502:physiology; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers / Q000592:standards; D010366:Peak Expiratory Flow Rate / Q000502:physiology; D012426:Russia; D016896:Treatment Outcome; D014797:Vital Capacity / Q000502:physiology
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate