The health-related quality of life effects of once-daily cetirizine HCl in patients with seasonal allergic rhinitis: a randomized double-blind, placebo-controlled trial

  1. M. J. Noonan1,
  2. G. D. Raphael2,
  3. A. Nayak3,
  4. L. Greos4,
  5. A. O. Olufade5,
  6. N. K. Leidy6,
  7. D. Champan5,
  8. B. Kramer5

Article first published online: 5 MAR 2003

DOI: 10.1046/j.1365-2222.2003.01596.x

Issue

Clinical & Experimental Allergy

Clinical & Experimental Allergy

Volume 33, Issue 3, pages 351–358, March 2003

Additional Information

How to Cite

Noonan, M. J., Raphael, G. D., Nayak, A., Greos, L., Olufade, A. O., Leidy, N. K., Champan, D. and Kramer, B. (2003), The health-related quality of life effects of once-daily cetirizine HCl in patients with seasonal allergic rhinitis: a randomized double-blind, placebo-controlled trial. Clinical & Experimental Allergy, 33: 351–358. doi: 10.1046/j.1365-2222.2003.01596.x

Author Information

  1. 1

    Allergy Associates, PC, Portland, Oregon,

  2. 2

    George Washington University, Bethesda, Maryland,

  3. 3

    Asthma & Allergy Research Associates, Bloomington, Illinois,

  4. 4

    Clinical Research Centers of Colorado, Wheat Ridge, Colorado,

  5. 5

    Pfizer Inc, New York, New York and

  6. 6

    MEDTAP International Inc, Bethesda, Maryland, USA

*Michael J. Noonan, 545 NE 47th Street, Suite 310, Portland, Oregon 97213, USA. E-mail: allergy1@asthma-research.com

  1. This study was presented at the 2000 American College of Allergy Asthma and Immunology Meeting.

Publication History

  1. Issue published online: 5 MAR 2003
  2. Article first published online: 5 MAR 2003
  3. Submitted 14 June 2002; revised 27 July 2002; accepted 11 October 2002

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Keywords:

  • cetirizine;
  • health-related quality of life;
  • seasonal allergic rhinitis

Summary

Background Seasonal allergic rhinitis (SAR) is characterized by subjectively irritating symptoms that can have a substantial impact on the patient's health-related quality of life (HRQL), adversely affecting physical and social or work activity, interpersonal relationships, and general psychological well-being. The objective of this study was to test the effect of cetirizine HCl 10 mg once daily on the HRQL of adult patients 18–65 years of age with SAR, concurrently assessing safety and efficacy.

Methods Randomized double-blind, placebo-controlled, parallel group trial conducted during the 1999 spring SAR season at 19 centers in the US. Following a 1-week placebo run-in period, qualified patients were randomized to cetirizine 10 mg, or placebo once daily for a 2-week treatment period. Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Total Symptom Severity Complex (TSSC) scores from baseline were the primary outcomes of interest.

Results Of the 611 patients enrolled, 403 (66%) were randomized. Cetirizine-treated patients reported significantly greater improvement in overall HRQL (P < 0.001) and in each of the seven domains of the RQLQ at all time-points (P < 0.05 to < 0.001) than the placebo group. They also experienced significantly greater symptom relief (P < 0.001) and were more satisfied with treatment (65% vs. 44%) compared to the placebo group. Correlations between symptomatic relief and overall HRQL improvement were moderate to strong and statistically significant (r = 0.49–0.68, P < 0.01).

Conclusions Results of this study are consistent with previous investigations, suggesting cetirizine HCl 10 mg taken once daily in the morning offers symptomatic relief that improves the HRQL of adults suffering from SAR.

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