A comparison of fluticasone propionate nasal spray and cetirizine in ragweed fall seasonal allergic rhinitis.

Abstract

BACKGROUND:

Intranasal corticosteroids are generally considered the most effective medication class for controlling allergic rhinitis. Previous comparative studies with oral antihistamines have been only partially informative due to a variety of variables encountered during their execution.

OBJECTIVE:

To compare fluticasone propionate nasal spray (FPNS) with the second-generation antihistamine cetirizine (oral tablet) and with placebo in a head-to-head study in a 2-week treatment study during fall ragweed season.

METHODS:

A total of 978 subjects were screened for this study. Six hundred and eighty-two subjects were randomized into the study (170 subjects, FPNS 200 mcg once daily; 170, cetirizine 10 mg once daily; 171, FPNS placebo; 171, cetirizine placebo) and comprised the intent-to-treat population. A 1-week placebo run-in was followed by a 2-week active treatment period during which time a total nasal symptom score (TNSS), total ocular symptom score, and the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire were collected.

RESULTS:

The primary efficacy end point was the mean change from baseline over the entire treatment period in A.M. reflective TNSS. The TNSS was the sum of the four individual nasal congestion, nasal itching, rhinorrhea, and sneezing scores, in which each symptom was scored on a scale of 0 to 3. Both FPNS and cetirizine improved the primary end point when compared with placebo during the active treatment period. Although there was a trend that favored FPNS with regard to the primary and secondary end points, there was not a statistical difference between the two treatments.

CONCLUSION:

FPNS and cetirizine were equally effective in treating fall seasonal allergic rhinitis during a 2-week head-to-head treatment investigation. Clinical trial NCT01916226, <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link>.

• Authors: Linda B Ford, Jonathan Matz, Todd Hankinson, Barbara Prillaman, George Georges
• Journal: Allergy and asthma proceedings (Allergy Asthma Proc) 2015 Jul-Aug Vol. 36 Issue 4 Pg. 313-9 ISSN: 1539-6304 [Electronic] United States
• PMID: 26108088 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Nasal Sprays
• Fluticasone
• Cetirizine

Topics

• Adolescent
• Adult
• Ambrosia (adverse effects)
• Cetirizine (administration & dosage, adverse effects)
• Female
• Fluticasone (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Nasal Sprays
• Rhinitis, Allergic, Seasonal (drug therapy, etiology)
• Seasons
• Treatment Outcome
• Young Adult