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- Title
Dose-ranging, placebo-controlled study of cetirizine nasal spray in adults with perennial allergic rhinitis.
- Authors
Clement, P.; Roovers, M. H. W.; Francillon, C.; Dodion, P.
- Abstract
A total of 360 patients with perennial allergic rhinitis were randomized in a placebo-controlled dose-finding study comparing three concentrations (0.06%, 0.125%, and 0.25%) of a cetirizine nasal spray administered three times a day for 2 weeks. The primary criterion of efficacy was the percentage of days with no or only mild symptoms of rhinitis (PDMax1) was evaluated by the patients. The median PDMax1 were 16.7%, 30.8%, 42.9%, and 26.7% for the placebo, 0.06%, 0.125%, and 0.25% groups, respectively. Although the global comparison among the four groups only approached statistical significance (<em>P</em>= 0.076), the difference (26.2%) between the placebo and 0.125%, groups was cIinically and statistically significant (<em>P</em> = 0.011). For the global evaluation by the investigator, the best results were seen in the 0.125% group (<em>P</em>= 0.03). The occurrence of adverse events did not differ among the four treatment groups and consisted mainly of nasal events, occurring in 22.5%, 17.1%, 12.9%, and 24.4% of the patients for the placebo, 0.06%, 0.125% and 0.25% groups, respectively results indicate that the (<em>P</em>=0.184). These results indicate that the 0.125% concentration is than placebo and offers the best therapeutic ratio.
- Subjects
PLACEBOS; ALLERGIC rhinitis; NASAL dilator strips; RESPIRATORY allergy; BEHAVIORAL medicine; RHINITIS
- Publication
Allergy, 1994, Vol 49, Issue 8, p668
- ISSN
0105-4538
- Publication type
Article
- DOI
10.1111/j.1398-9995.1994.tb00138.x