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Question In children with asthma, does adding salmeterol to fluticasone affect risks for serious asthma events or exacerbations? Methods Design Randomized controlled trial (RCT) (VESTRI). ClinicalTrials.gov NCT01462344. Allocation {Concealed}*.† Blinding Blinded† (patients, clinicians, investigators, outcome adjudicators, safety committee, {data collectors, and data analysts}*). Patients and investigators were not blinded to fluticasone dose. Follow-up period 6 months after the first study drug dose or 7 days after the last dose, whichever was longer (approximately 26 wk). Setting 567 clinical centers in 32 countries. Patients 6250 children 4 to 11 years of age (mean age 7.6 y, 61% boys) who had been consistently using asthma medication in the past 4 weeks, had exacerbations in the past 12 months but not the past 30 days, and had been assessed with the Childhood Asthma Control Test. Exclusion criteria included life-threatening or unstable asthma. Intervention Fluticasone-salmeterol (n = 3107) or fluticasone alone (n = 3101) twice daily via a DISKUS device. Fluticasone propionate was delivered at doses of 100 µg or 250 µg. Salmeterol dose was 50 µg. Outcomes Serious asthma events (asthma-related deaths, intubations, or hospitalizations). Secondary outcomes included asthma exacerbations that required systemic glucocorticoids for ࣙ 3 days or a depot injection of glucocorticoids. 6202 patients were needed to determine noninferiority of fluticasone-salmeterol vs fluticasone alone for serious asthma events based on an estimated fluticasone-alone event rate of 0.7% over 26 weeks (noninferiority margin for treatment hazard ratio was 2.675, 90% power, 1-sided α = 0.025). Patient follow-up 99% (intention-to-treat analysis). Main results Groups did not differ for serious asthma events or exacerbations (Table). Conclusion In children with asthma, adding salmeterol to fluticasone did not increase risk for serious asthma events or reduce exacerbations. [ABSTRACT FROM AUTHOR]

Question In adolescents and adults with moderate to severe asthma, does adding salmeterol to fluticasone affect risks for serious asthma events or exacerbations? Methods Design Randomized controlled trial (RCT) (AUSTRI). ClinicalTrials.gov NCT01475721. Allocation Concealed.* Blinding Blinded* (patients, clinicians, investigators, outcome adjudicators, safety committee, {data collectors, and data analysts}†). Patients and investigators were not blinded to fluticasone dose. Follow-up period 6 months after the first study drug dose or 7 days after the last dose, whichever was greater (approximately 26 wk). Setting 694 clinical centers in 33 countries. Patients 11 751 adolescents and adults ࣙ 12 years of age (mean age 43 y, 66% girls and women) who had asthma for ࣙ 1 year, used daily asthma medication, and had been hospitalized or used systemic gluococorticoids for asthma exacerbations in the past 12 months but not the past 30 days. Exclusion criteria included life-threatening or unstable asthma or a smoking history of > 10 pack-years. Intervention Fluticasone-salmeterol (n = 5834) or fluticasone alone (n = 5845), twice daily via a masked DISKUS dry-powder inhaler for 26 weeks. Fluticasone propionate was delivered at doses of 100 µg, 250 µg, or 500 µg. Salmeterol dose was 50 µg. Outcomes Serious asthma events (asthma-related deaths, intubations, or hospitalizations). Secondary outcomes included asthma exacerbations that required systemic glucocorticoids for ࣙ 3 days, hospitalization, or emergency department visits with systemic glucocorticoid treatment. 11 664 patients were needed to determine noninferiority of fluticasone-salmeterol vs fluticasone alone for serious asthma events based on an estimated fluticasone-alone event rate of 0.75% over 26 weeks (noninferiority margin for treatment hazard ratio was 2.0, 90% power, 1-sided α = 0.025). Patient follow-up 98% (intention-to-treat analysis). Main results Groups did not differ for serious asthma events (Table). The fluticasone-salmeterol group had fewer exacerbations than the fluticasone-alone group (Table). Conclusion In adolescents and adults with moderate to severe asthma, adding salmeterol to fluticasone did not increase risk for serious asthma events and reduced exacerbations. [ABSTRACT FROM AUTHOR]