For children 12 years of age and older:
Two inhalations inhaled orally twice daily (morning and evening).
Each inhalation contains either 100 mcg or 200 mcg of mometasone with 5 mcg of formoterol.
Maximum Daily Dose: 800 mcg of mometasone; 20 mcg of formoterol
-The starting dose should be determined based on patient's previous asthma therapy.
-Patients previously on inhaled medium dose corticosteroids should be started on the 100 mcg/5 mcg strength.
-Patients previously on inhaled high dose corticosteroids should be started on the 200 mcg/5 mcg strength.
-Not for use in treatment of acute bronchospasm.
Use: Indicated for patients 12 years of age and older who have inadequate control on a long-term asthma control medication or whose disease severity requires initiation of an inhaled corticosteroid and long-acting beta2-adrenergic agonist
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.