title: The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma.
abstract: BACKGROUND
  For children older than 5 years with asthma who remain symptomatic despite inhaled corticosteroid (ICS) therapy, the preferred treatment is to add an inhaled long-acting beta2-agonist vs increasing the ICS dose.
  
  
  OBJECTIVE
  To compare the safety of twice-daily treatment with inhaled fluticasone propionate plus the inhaled long-acting beta2-agonist salmeterol with that of fluticasone propionate used alone in children aged 4 to 11 years with persistent asthma.
  
  
  METHODS
  A randomized, multicenter, double-blind, active-controlled, parallel-group study in 203 children with persistent asthma who were symptomatic during ICS therapy. Patients received fluticasone propionate-salmeterol (100/50 microg) or fluticasone propionate (100 microg) alone twice daily for 12 weeks.
  
  
  RESULTS
  The safety profile of fluticasone propionate-salmeterol was similar to that of fluticasone propionate alone. The overall incidence of adverse events was 59% for fluticasone propionate-salmeterol and 57% for fluticasone propionate. Both treatments were well tolerated. Two patients receiving fluticasone propionate-salmeterol and 5 receiving fluticasone propionate withdrew from the study because of worsening asthma. Changes in heart rate, blood pressure, and laboratory variables were infrequent and were similar between treatments. No patients had clinically significant abnormal electrocardiographic findings during treatment. Geometric mean 24-hour urinary cortisol excretion at baseline and after 12 weeks of treatment was comparable within and between groups; no patient in either group had abnormally low 24-hour urinary cortisol excretion after 12 weeks of treatment. The incidence of withdrawals due to asthma exacerbations was 2% in the fluticasone propionate-salmeterol group and 5% in the fluticasone propionate group.
  
  
  CONCLUSIONS
  In pediatric patients with persistent asthma, fluticasone propionate-salmeterol twice daily was well tolerated, with a safety profile similar to that of fluticasone propionate used alone.
authors.affiliation: Southeast Asthma and Allergy Center, Tallahassee, Florida 32308, USA. rmalone@rose.net
authors.forename: Randolph
authors.initials: R
authors.lastname: Malone
authors.forename: Craig
authors.initials: C
authors.lastname: LaForce
authors.forename: Sai
authors.initials: S
authors.lastname: Nimmagadda
authors.forename: Lynne
authors.initials: L
authors.lastname: Schoaf
authors.forename: Karen
authors.initials: K
authors.lastname: House
authors.forename: Anna
authors.initials: A
authors.lastname: Ellsworth
authors.forename: Paul
authors.initials: P
authors.lastname: Dorinsky
mesh_terms: D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001794:Blood Pressure / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004562:Electrocardiography; D005260:Female; D000068298:Fluticasone; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D008297:Male; D000068299:Salmeterol Xinafoate
chemical_list: D000318:Adrenergic beta-Agonists; D000730:Androstadienes; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol; D006854:Hydrocortisone