Efficacy and safety of high‐dose budesonide/formoterol (Symbicort®) compared with budesonide administered either concomitantly with formoterol or alone in patients with persistent symptomatic asthma
- 19 April 2006
- journal article
- research article
- Published by Wiley in Respirology
- Vol. 11 (3) , 276-286
- https://doi.org/10.1111/j.1440-1843.2006.00856.x
Abstract
Budesonide/formoterol 160/4.5 microg, two inhalations bd, is an effective and well-tolerated maintenance therapy for patients not controlled on inhaled corticosteroids alone. The authors assessed the efficacy and safety of a higher dose of budesonide/formoterol in patients with persistent symptomatic asthma.This was a 24-week, double-blind, double-dummy randomized study. Budesonide/formoterol 320/9 microg, two inhalations bd (1280/36 microg/day), was compared with corresponding doses of budesonide during weeks 1-12 and budesonide plus formoterol via separate inhalers during weeks 1-24. Efficacy was assessed during weeks 1-12; the primary variable was morning PEF. Safety was assessed over weeks 1-24.Patients (n=456; aged 12-79 years) had a mean reversibility in FEV1 of 28% and mean pre-study inhaled corticosteroid dose of 1038 microg/day. Mean morning PEF increased by 37 L/min and 36 L/min with budesonide/formoterol and budesonide plus formoterol, respectively, versus an increase of 5 L/min with budesonide (P<0.001 for both vs. budesonide). Budesonide/formoterol increased time to first mild exacerbation (P<0.005) versus budesonide. Budesonide/formoterol and budesonide plus formoterol had similar efficacy. All treatments were well tolerated and the incidence of class-related adverse events was similarly low in all groups. Changes in serum potassium and plasma cortisol were comparable across treatments.High-dose budesonide/formoterol (320/9 microg, two inhalations bd) is effective and well tolerated in patients with persistent symptomatic asthma. The findings also support the safety of regular high-dose formoterol (36 microg/day).Keywords
This publication has 30 references indexed in Scilit:
- Budesonide/formoterol in a single inhaler rapidly relieves methacholine-induced moderate-to-severe bronchoconstrictionPulmonary Pharmacology & Therapeutics, 2004
- Adjustable maintenance dosing with budesonide/formoterol compared with fixed-dose salmeterol/fluticasone in moderate to severe asthmaCurrent Medical Research and Opinion, 2004
- Tolerability of a high dose of budesonide/formoterol in a single inhaler in patients with asthmaPulmonary Pharmacology & Therapeutics, 2003
- New year: new editorsThorax, 2003
- Onset of Bronchodilation of Budesonide/Formoterol vs. Salmeterol/Fluticasone in Single InhalersPulmonary Pharmacology & Therapeutics, 2001
- Oxis®(formoterol given by Turbuhaler®) showed as rapid an onset of action as salbutamol given by a pMDIRespiratory Medicine, 2000
- Effect of Inhaled Formoterol and Budesonide on Exacerbations of AsthmaNew England Journal of Medicine, 1997
- Inhaled dry-powder formoterol and salmeterol in asthmatic patients: onset of action, duration of effect and potencyEuropean Respiratory Journal, 1997
- Effects of the long acting beta agonist formoterol on asthma control in asthmatic patients using inhaled corticosteroids. The Netherlands and Canadian Formoterol Study InvestigatorsThorax, 1997
- Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroidThe Lancet, 1994