title: Efficacy and safety of topical combinations of ipratropium and xylometazoline for the treatment of symptoms of runny nose and nasal congestion associated with acute upper respiratory tract infection.
abstract: BACKGROUND
  Rhinorrhea and nasal congestion are simultaneous symptoms associated with the common cold. This study investigated the efficacy and safety of a combination nasal spray of ipratropium and xylometazoline for simultaneous treatment of these symptoms.
  
  
  METHODS
  The trial was a multicenter double-blind, parallel-group, randomized design on patients with common cold symptoms. Patients scored symptoms of runny nose and nasal congestion and recorded adverse events in a diary for up to 7 days. Patients also recorded tissue use. The five test treatments consisted of ipratropium, 0.6 mg/mL, and xylometazoline, 1.0 mg/mL; ipratropium, 0.6 mg/mL, and xylometazoline, 0.5 mg/mL; ipratropium, 0.6 mg/mL; xylometazoline, 1.0 mg/mL; and placebo solution.
  
  
  RESULTS
  Eight hundred sixty-four patients were screened and 786 patients received treatment. One day after treatment there was a clear separation between the scores for the placebo and ipratropium treatment groups for rhinorrhea and between the placebo and xylometazoline treatment groups for congestion. Both ipratropium/xylometazoline 1.0 and ipratropium/xylometazoline 0.5 treatments were superior to xylometazoline with respect to rhinorrhea (p < 0.0001) and superior to ipratropium with respect to nasal congestion scores (p < 0.001). Both the ipratropium combination treatments had significantly lower tissue use than the xylometazoline treatment group (p < 0.0001). Adverse events were distributed equally between the treatments, except mucus tinged with blood, epistaxis, nasal passage irritation, and nasal dryness, which had a higher incidence in the three groups that received medicines containing ipratropium.
  
  
  CONCLUSIONS
  The results indicate that a combination medicine of ipratropium and xylometazoline is safe and effective for treatment of rhinorrhea and nasal congestion associated with common cold.
authors.affiliation: Common Cold Centre, Cardiff School of Biosciences, Cardiff University, United Kingdom. eccles@cf.ac.uk
authors.forename: Ronald
authors.initials: R
authors.lastname: Eccles
authors.forename: Anette
authors.initials: A
authors.lastname: Pedersen
authors.forename: Dan
authors.initials: D
authors.lastname: Regberg
authors.forename: Heikki
authors.initials: H
authors.lastname: Tulento
authors.forename: Peter
authors.initials: P
authors.lastname: Borum
authors.forename: Pär
authors.initials: P
authors.lastname: Stjärne
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018680:Cholinergic Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D009241:Ipratropium / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D014663:Nasal Decongestants / Q000008:administration & dosage* / Q000627:therapeutic use; D012141:Respiratory Tract Infections / Q000150:complications*; D012220:Rhinitis / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D000316:Adrenergic alpha-Agonists; D018680:Cholinergic Antagonists; D007093:Imidazoles; D014663:Nasal Decongestants; D009241:Ipratropium; C009695:xylometazoline