title: Inhaled corticosteroid dosing: double for nothing?
abstract: Two recent trials from the National Heart, Lung, and Blood Institute's asthma clinical trials networks raise a concern about using double the dose of an inhaled corticosteroid (ICS) as a positive control arm in clinical trials of add-on therapy. The literature evaluating the response to doubling the dose of an ICS is briefly reviewed. The vast majority of studies do not demonstrate a significant positive benefit from doubling the dose of an ICS but do show improvement with 4-fold increases that is equal to or greater than that of add-on long-acting bronchodilators. It is recommended that doubling the dose of an ICS no longer be considered a positive comparator arm in clinical trials, although it might be beneficial in individual patients.
authors.affiliation: Department of Pediatrics, University of New Mexico, Albuquerque, NM 87131-0001, USA. hwkelly@salud.unm.edu
authors.forename: H William
authors.initials: HW
authors.lastname: Kelly
mesh_terms: D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D016896:Treatment Outcome
chemical_list: D018927:Anti-Asthmatic Agents; D005938:Glucocorticoids; D019819:Budesonide