Results The analyses included 16 randomized clinical trials (N = 22 748 patients), 15 of which evaluated SMART as a combination therapy with budesonide and formoterol in a dry-powder inhaler. Among patients aged 12 years or older (n = 22 524; mean age, 42 years; 14 634 [65%] were female), SMART was associated with a reduced risk of asthma exacerbations compared with the same dose of inhaled corticosteroids and LABA as the controller therapy (RR, [95% CI, to ]; RD, −% [95% CI, −% to −%]) and a higher dose of inhaled corticosteroids and LABA as the controller therapy (RR, [95% CI, to ]; RD, −% [95% CI, −% to −%]). Similar results were seen when SMART was compared with inhaled corticosteroids alone as the controller therapy. Among patients aged 4 to 11 years (n = 341; median age, 8 [range, 4-11] years; 69 [31%] were female), SMART was associated with a reduced risk of asthma exacerbations compared with a higher dose of inhaled corticosteroids as the controller therapy (RR, [95% CI, to ]; RD, −% [95% CI, −% to −%]) or the same dose of inhaled corticosteroids and LABA as the controller therapy (RR, [95% CI, to ]; RD, −% [95% CI, −% to −%]).
Inhaled corticosteroids are medications used to treat asthma. They are taken by using an inhaler. This medication should be taken consistently so that it decreases inflammation in the airways of your lungs and prevents asthma flare-ups. Inhaled corticosteroids are considered the most effective long term usage medication for control and management of asthma. Depending upon the severity of your asthma, your physician may combine an inhaled corticosteroid with a long-acting beta-2 agonist to treat your condition. Oral and intravenous corticosteroids may be required for acute asthma flare-ups or for severe symptoms.
We identified seven randomised trials (5997 participants) of good quality with a duration of six months to three years. All of the trials compared ICS/LABA combination inhalers with LABA and ICS as individual components. Four of these trials included fluticasone and salmeterol monocomponents and the remaining three included budesonide and formoterol monocomponents. There was no statistically significant difference in our primary outcome , the number of patients experiencing exacerbations ( odds ratio ( OR ) ; 95% CI to ), or the rate of exacerbations per patient year (rate ratio ( RR ) ; 95% CI to ) between inhaled corticosteroids and long-acting beta 2 -agonists. The incidence of pneumonia, our co-primary outcome , was significantly higher among patients on inhaled corticosteroids than on long-acting beta 2 -agonists whether classified as an adverse event ( OR ; 95% CI to ) or serious adverse event (Peto OR ; 95% CI to ). Results of the secondary outcomes analysis were as follows. Mortality was higher in patients on inhaled corticosteroids compared to patients on long-acting beta 2 -agonists (Peto OR ; 95% CI to ), although the difference was not statistically significant . Patients treated with beta 2 -agonists showed greater improvements in pre-bronchodilator FEV 1 compared to those treated with inhaled corticosteroids ( mean difference ( MD ) mL; 95% CI to ), whilst greater improvements in health-related quality of life were observed in patients receiving inhaled corticosteroids compared to those receiving long-acting beta 2 -agonists (St George's Respiratory Questionnaire (SGRQ) MD -; 95% CI - to -). In both cases the differences were statistically significant but rather small in magnitude. There were no statistically significant differences between ICS and LABA in the number of hospitalisations due to exacerbations, number of mild exacerbations, peak expiratory flow, dyspnoea , symptoms scores, use of rescue medication, adverse events, all cause hospitalisations, or withdrawals from studies.