title: A randomized, double-blind, parallel trial comparing capsaicin nasal spray with placebo in subjects with a significant component of nonallergic rhinitis.
abstract: OBJECTIVE
  To investigate the efficacy and safety of ICX72 or Sinus Buster, a proprietary homeopathic preparation of Capsicum annum and Eucalyptol, versus placebo administered continuously over 2 weeks in subjects with a significant component of nonallergic rhinitis (NAR).
  
  
  METHODS
  Forty-two consented subjects meeting inclusion/exclusion criteria were randomized to ICX72 (n = 20) or control (n = 22) administered twice daily over 2 weeks. The primary endpoint was change in total nasal symptom scores (TNSS) from baseline to end of study. Secondary endpoints included changes in individual symptom scores (ISS) over 2 weeks and average time to first relief. Mean TNSS and ISS were recorded after single dosing at different intervals over 60 minutes. Rhinitis quality-of-life, rescue medication, and safety endpoints were analyzed.
  
  
  RESULTS
  ICX72 versus placebo subjects exhibited significant differences in changes from baseline to end of study for TNSS and each ISS (P < .01), had an average time to first relief of 52.6 seconds (P < .01), and improvement in nasal congestion, sinus pain, sinus pressure, and headache at 5, 10, 15, and 30 minutes, persisting at 60 minutes for nasal congestion and sinus pain (P < .05). No difference between groups in adverse events or rescue medication was observed. ICX72 versus placebo subjects experienced no rebound congestion or impaired olfaction at the end of the study.
  
  
  CONCLUSIONS
  This is the first controlled trial demonstrating intranasal capsaicin, when used continuously over 2 weeks, rapidly and safely improves symptoms in rhinitis subjects with a significant NAR component.
authors.affiliation: Department of Internal Medicine, Division of Immunology/Allergy Section, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267-0563, USA. jonathan.bernstein@uc.edu
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Bernstein
authors.forename: Benjamin P
authors.initials: BP
authors.lastname: Davis
authors.forename: Jillian K
authors.initials: JK
authors.lastname: Picard
authors.forename: Jennifer P
authors.initials: JP
authors.lastname: Cooper
authors.forename: Shu
authors.initials: S
authors.lastname: Zheng
authors.forename: Linda S
authors.initials: LS
authors.lastname: Levin
mesh_terms: D000293:Adolescent; D000328:Adult; D002211:Capsaicin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006261:Headache; D006801:Humans; D008297:Male; D008875:Middle Aged; D015508:Nasal Obstruction; D059085:Nasal Sprays; D010919:Placebos / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D012220:Rhinitis / Q000188:drug therapy* / Q000503:physiopathology; D011795:Surveys and Questionnaires
chemical_list: D059085:Nasal Sprays; D010919:Placebos; D002211:Capsaicin