title: Effective dose range of mometasone furoate nasal spray in the treatment of acute rhinosinusitis.
abstract: BACKGROUND
  Mometasone furoate nasal spray (MFNS) 400 microg, twice daily, as adjunctive treatment with oral antibiotic significantly improved symptoms of recurrent rhinosinusitis.
  
  
  OBJECTIVE
  To evaluate the effectiveness and safety of MFNS 200 microg, twice daily, and 400 microg, twice daily, compared with placebo as adjunctive treatment with oral antibiotic for acute rhinosinusitis.
  
  
  METHODS
  In this multicenter, double-blind, placebo-controlled study, 967 outpatients with computed tomographic scan-confirmed moderate to severe rhinosinusitis received amoxicillin/clavulanate potassium (Augmentin, GlaxoSmithKline, Research Triangle Park, NC) 875 mg, twice daily, for 21 days with adjunctive twice daily MFNS 200 microg, MFNS 400 microg, or placebo nasal spray. Patients recorded scores of six rhinosinusitis symptoms and any adverse events twice daily. Pre- and postcosyntropin-stimulation plasma cortisol levels were measured in a subset of patients at selected study sites.
  
  
  RESULTS
  Treatment with MFNS 200 microg or 400 microg, twice daily, produced significantly greater improvements in total symptoms score (primary efficacy variable) day 1 to day 15 average (50% and 51%, respectively) than placebo (44%, P < or = 0.017). Both doses of MFNS produced significant total symptoms score improvement over placebo by day 4, and maintained efficacy over the entire 21-day study. Relief of individual symptoms showed a similar pattern. Both doses of MFNS were well tolerated, and adverse events were similar to that of placebo. Cosyntropin stimulation showed no evidence of hypothalamic-pituitary-adrenal axis suppression.
  
  
  CONCLUSIONS
  As adjunctive therapy to oral antibiotic treatment, MFNS at doses of 200 microg or 400 microg, twice daily, was well tolerated and significantly more effective in reducing the symptoms of rhinosinusitis than antibiotic therapy alone.
authors.affiliation: Asthma and Allergy Research Associates, PC, Normal, Illinois 61761, USA. asthma2@aol.com
authors.forename: Anjuli S
authors.initials: AS
authors.lastname: Nayak
authors.forename: Guy A
authors.initials: GA
authors.lastname: Settipane
authors.forename: Andrew
authors.initials: A
authors.lastname: Pedinoff
authors.forename: B Lauren
authors.initials: BL
authors.lastname: Charous
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
authors.forename: S James
authors.initials: SJ
authors.lastname: Zinreich
authors.forename: Richard R
authors.initials: RR
authors.lastname: Lorber
authors.forename: Ger
authors.initials: G
authors.lastname: Rikken
authors.forename: Melvyn R
authors.initials: MR
authors.lastname: Danzig
mesh_terms: D000208:Acute Disease; D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003366:Cosyntropin / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D012852:Sinusitis / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000336:Aerosols; D000893:Anti-Inflammatory Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D003366:Cosyntropin; D006854:Hydrocortisone