Efficacy and safety of an oral formulation of cetirizine and prolonged-release pseudoephedrine versus xylometazoline nasal spray in nasal congestion

Arzneimittelforschung. 2001 Nov;51(11):904-10. doi: 10.1055/s-0031-1300135.

Abstract

The aim of this study was to compare the decongestant properties and tolerability of the sympathomimetic xylometazoline hydrochloride 0.1% (CAS 1218-35-5, XMZ) and an oral formulation of cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg (CAS 83881-51-0 and 90-82-4, CTZ/PSE; Cirrus). Thirty-six asymptomatic patients suffering from perennial allergic rhinitis from house dust mite were randomized to this open two-period crossover study. Patients received the study medications for four days each. In each period, treatments were taken twice a day. On day 1 in each period, immediately after the first dose of medication, patients were challenged with Dermatophagoides pteronyssinus extract 1 in the Vienna Challenge Chamber for 5 h. Primary efficacy parameters were nasal congestion evaluated by digital analysis of nasal cavity photographs and nasal airflow. Furthermore amounts of nasal secretions, nasal and ocular symptoms were recorded. In addition, 5 independent Ear-Nose-Throat specialists also assessed nasal cavity photographs. Statistical analyses were conducted at the 5% level of significance. Digital analysis of the nasal cavity photographs as well as nasal airflow measurements did not differentiate XMZ from CTZ/PSE. Ratings of the photographs of the nasal cavity emphasized the rapid onset of XMZ. No clinically relevant adverse events were recorded. This rapid onset of action but short-lived effect of topical xylometazoline 0.1% should be balanced against the consistent and prolonged effect of systemic cetirizine/pseudoephedrine combination in the treatment of perennial allergic rhinitis as no significant differences between these 2 medications were noted regarding their decongestant properties. With the exception of nasal obstruction, all subjective symptoms as well as the global condition were significantly better under CTZ/PSE. Amounts of nasal secretions during these sessions were significantly lower with CTZ/PSE.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intranasal
  • Administration, Oral
  • Adult
  • Blood Pressure / drug effects
  • Cetirizine / administration & dosage
  • Cetirizine / adverse effects
  • Cetirizine / therapeutic use*
  • Cross-Over Studies
  • Delayed-Action Preparations
  • Double-Blind Method
  • Ephedrine / administration & dosage
  • Ephedrine / adverse effects
  • Ephedrine / therapeutic use*
  • Female
  • Histamine H1 Antagonists / administration & dosage
  • Histamine H1 Antagonists / adverse effects
  • Histamine H1 Antagonists / therapeutic use*
  • Humans
  • Imidazoles / administration & dosage
  • Imidazoles / adverse effects
  • Imidazoles / therapeutic use*
  • Male
  • Nasal Decongestants / administration & dosage
  • Nasal Decongestants / adverse effects
  • Nasal Decongestants / therapeutic use*
  • Nasal Mucosa / metabolism
  • Nasal Obstruction / drug therapy*
  • Peak Expiratory Flow Rate
  • Respiratory Function Tests
  • Rhinitis, Allergic, Perennial / drug therapy

Substances

  • Delayed-Action Preparations
  • Histamine H1 Antagonists
  • Imidazoles
  • Nasal Decongestants
  • Ephedrine
  • xylometazoline
  • Cetirizine