Budesonide/formoterol

Beractant (Survanta) Budesonide (Rhinocort Aqua, Pulmicort) Budesonide/Formoterol (Symbicort)... 

Budesonide/Formoterol (Symbicort) [Anti-inflammatory> Bronchodilator/Beta-2-Agonist] WARNING Long-acting... 

O Byrne PM, Bisgaard H, Godard PP et al. Budesonide-formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005 171 129-36. 

Data relating to budesonide + formoterol therapy from six randomized controlled trials of at least 6 months n = 14 346) have been analysed [60 ]. SMART therapy was well tolerated compared with fixed-dose alternatives, and there was no increased risk of death or cardiac-related serious adverse events or withdrawals because of adverse events asthma-related serious adverse events and withdrawals were significantly reduced. Limitations of the randomized controlled trials were noted, particularly exclusion of patients with co-morbidities, necessitating continuing surveillance. 

A 12-month open study in primary care showed no clinically important differences in adverse events between flexible and fixed dosing of budesonide - - formoterol. Maintenance and reliever therapy was associated with a significantly lower daily dose of budesonide and direct cost savings, with at least equivalent efficacy [63 ] there were similar findings in other studies [64. ... 

Sears MR, Radner F. Safety of budesonide/formoterol maintenance and reliever therapy in asthma trials. Respir Med 2009 103(12) 1960-8. 

Demoly P, Louis R, Soes-Petersen U, Naya I, Carlsheimer A, Worth H, Almeida J, Sears MR. Budesonide/ formoterol maintenance and reliever... 

Pavord ID, Jeffery PK, Qiu Y, Zhu J, Parker D, Carlsheimer A, Naya I, Barnes NC. Airway inflammation in patients with asthma with high-fixed or low-fixed plus as-needed budesonide/ formoterol J Allergy Clin Immunol 2009 123(5) 1083-9, 1089.el-7. 

Stallberg B, Ekstrom T, Neij F, Olsson P, Skoogh BE, Wennergren G, Lofdahl CG. SHARE Trial Group. A real-life cost-effectiveness evaluation of budesonide/ formoterol maintenance and reliever therapy in asthma. Respir Med 2008 102(10) 1360-70. 

Louis R, Joos G, Michils A, Vandenhoven G. A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management Int J Clin Pract 2009 63(10) 1479-88. 

The current randomised, double-blind, double-dummy, parallel-group, 12-month multicentre study evaluated the effect of budesonide/formoterol pressurised metred-dose inhaler (pMDI) on COPD exacerbations [6 ]. The method follows a 2-week nm-in during which COPD patients aged >40 years with an exacerbation history discontinued medications except inhaled corticosteroids 1219 patients were randomised 1 1 1 to twice-daily budesonide/formoterol pMDl 320/9 Jig, budesonide/formoterol pMDI 160/9 jig, or formoterol dry powder inhaler 9 jig. An exacerbation was defined as COPD worsening requiring oral corticosteroids and/or hospitalisation. 

Aposthoc analysis with antibiotic treatment added to the exacerbation definition was also performed. Budesonide / formoferol 320/9 jig and 160/9 jig reduced exacerbation rates (number per patient-treatment year) by 34.6% and 25.9%, respectively, versus formoterol. Budesonide/formoterol 320/9 prolonged the time to first exacerbation versus formoterol, corresponding to a 21.2% reduction in hazard ratio. Exacerbation rates (number per patient-treatment year) including antibiotic treatment (post hoc analysis) were reduced by 25.9% and 18.7% with budesonide/formoterol 320/9 and 160/9, respectively, versus formoterol. 

Both budesonide/formoterol doses were well tolerated with safety profiles similar to formoterol. Pneumonia adverse events occurred in 6.4%, 4.7% and 2.7% of patients in the budesonide/formoterol 320/9, 160/9, and formoterol groups. Over 12 months, both budesonide/formoterol doses reduced the exacerbation rate (defined with or without antibiotic treatment) versus formoterol. 

Sharafkhaneh A, Southard JG, Goldman M, Uryniak T, Martin UJ. Effect of budesonide/formoterol pMDl on COPD exacerbation a doubleblind, randomized study. Resp Med 2012 106(2) 257-68. 

Another double-blind trial randomised 1219 COPD patients to budesonide/formoterol (320/9 jig), budesonide/ formoterol (160/9 rg), or formoterol alone (9 xg). A dose-dependent increase in the frequency of pneumonia was found in the groups receiving fluticasone with formoterol (320/9 frequency = 6.4%, 160/9 frequency = 4.7%) compared to those that received formoterol alone frequency = 2.7%) [S -]. 

The efficacy and safety of formoterol when added to ICS was also assessed in a 52-week randomised controlled trial. This trial included 742 self-reported African Americans, older than 12 years of age, with moderate-to-severe asthma [34 ]. The patients were randomised to receive either budesonide/formoterol versus budesonide alone. Both arms of the study had similar safety characteristics, with the most frequently reported adverse effects being headache (9.5% of patients receiving the combination vs 7.7% in the budesonide arm), nasopharyngitis (6.9% vs 8.0%), sinusitis (4.0% vs 6.3%), and upper respiratory tract infections (5.8% vs 4.4%). 

Brown RW, O Brien CD, Martin UJ, Uryniak T, Lampl KL. Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients a randomised controlled trial. J Allergy Clin Immunol August 2012 130(2) 362-7. e9. 

Cazzola M. Single inhaler budesonide/formoterol in exacerbations of chrorric obstructive pulmonary disease. Pulm Pharmacol Ther 2006 19 79-89. 

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