title: Mometasone furoate nasal spray plus oxymetazoline nasal spray: short-term efficacy and safety in seasonal allergic rhinitis.
abstract: BACKGROUND
  Allergic rhinitis (AR) and associated congestion adversely affect patients' lives. The intranasal corticosteroid mometasone furoate nasal spray (MFNS) is effective for AR symptoms including nasal congestion, and the intranasal decongestant oxymetazoline (OXY) is effective against nasal congestion, but the combination has not been fully studied. This study was designed to assess the efficacy of the combination of MFNS and OXY for the relief of seasonal allergic rhinitis (SAR) symptoms.
  
  
  METHODS
  This phase 2 controlled clinical trial randomized adolescent and adult subjects (≥12 years; 2-year SAR) to MFNS q.d. (200 μg) + 3 sprays/nostril of OXY 0.05% (MFNS + OXY3); MFNS q.d. + 1 spray/nostril of OXY (MFNS + OXY1); MFNS q.d.; OXY b.i.d.; or placebo for 15 days, with 1-week follow-up. Coprimary end points were change from baseline in morning/evening (A.M./P.M.) instantaneous (NOW) total nasal symptom score (TNSS) over days 1-15 and AUC (AUC[0-4 hr]) change from baseline in day 1 congestion.
  
  
  RESULTS
  In 705 subjects, both combinations reduced A.M./P.M. NOW TNSS over days 1-15 significantly more than OXY b.i.d. or placebo (p ≤ 0.002). Mean standardized AUC(0-4 hr) day 1 congestion change from baseline was significantly greater in combination and OXY b.i.d. groups (MFNS + OXY3, -0.92; MFNS + OXY1, -0.80; OXY b.i.d., -1.06) versus placebo (-0.57) and MFNS q.d. (-0.63). Combinations and MFNS q.d. were significantly effective for A.M./P.M. NOW TNSS over each weekly period; OXY b.i.d. was superior to placebo in week 1. Adverse events (AEs) were few and similar across treatments; one MFNS q.d. and one placebo subject experienced a serious AE, with neither considered treatment related.
  
  
  CONCLUSIONS
  Combining MFNS with OXY relieves SAR symptoms, including congestion, with faster onset of action than MFNS q.d. and better sustained efficacy than OXY b.i.d.
authors.affiliation: Allergy & Asthma Medical Group & Research Center, San Diego, California 92123, USA. eomeltzer@aol.com
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: Bruce M
authors.initials: BM
authors.lastname: Prenner
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.forename: Tulin
authors.initials: T
authors.lastname: Shekar
authors.forename: Ariel A
authors.initials: AA
authors.lastname: Teper
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D015508:Nasal Obstruction / Q000188:drug therapy*; D059085:Nasal Sprays; D010109:Oxymetazoline / Q000008:administration & dosage* / Q000009:adverse effects; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D006634:Histamine H1 Antagonists; D059085:Nasal Sprays; D010109:Oxymetazoline