One-year safety and efficacy of budesonide/formoterol in a single inhaler (Symbicort ® Turbuhaler ®) for the treatment of asthma

• Published in: Respiratory medicine 2003-06, Vol.97 (6), p.702-708
• Main Authors: ROSENHALL, L., ELVSTRAND, A., TILLING, B., VINGE, I., JEMSBY, P., STAHL, E., JERRE, F., BERGQVIST, P.B.F.
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Adolescent; Adult; Aged; asthma; Asthma - drug therapy; Biological and medical sciences; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; budesonide; Budesonide - administration & dosage; Budesonide - adverse effects; Chronic obstructive pulmonary disease, asthma; Drug Combinations; Drug Therapy, Combination; Ethanolamines - administration & dosage; Ethanolamines - adverse effects; Female; Forced Expiratory Volume - drug effects; formoterol; Formoterol Fumarate; Humans; Male; Medical sciences; Middle Aged; Nebulizers and Vaporizers; Pneumology; single inhaler; Treatment Outcome; Vital Capacity - drug effects
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1053/rmed.2003.1504

Background: A budesonide/formoterol single inhaler has been developed for convenient treatment of patients whose asthma is inadequately controlled by inhaled glucocorticosteroids alone. Objectives: To compare long-term safety and efficacy of budesonide/formoterol single inhaler with budesonide plus formoterol via separate inhalers in adults with asthma. Methods: In this open, randomized, parallel-group 6-month extension conducted in a subset of centres from a previous 6-month study, patients ( n=321) received two inhalations bid of budesonide/formoterol (Symbicort ® Turbuhaler ®) 160/4.5 μg delivered dose or corresponding doses of budesonide (Pulmicort ® Turbuhaler ®) plus formoterol (Oxis ® Turbuhaler ®) via separate inhalers. Results: Significantly fewer patients receiving budesonide/formoterol single inhaler withdrew compared with budesonide plus formoterol (9 vs. 19%, P =0.008). Incidence and severity of AEs were low and similar in both groups. No clinically important differences between groups, or changes, were identified in laboratory measurements, vital signs or ECG. Treatments produced similar improvements in lung function, ACQ scores and Mini AQLQ domains that were maintained throughout 12 months. Conclusions: Budesonide/formoterol in a single inhaler is as safe and effective in the long-term treatment of asthma as budesonide plus formoterol via separate inhalers. The lower number of withdrawals with budesonide/formoterol may reflect better adherence to treatment compared with budesonide plus formoterol.