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Efficacy data in seasonal allergic rhinitis

Children’s REACTINE® improved allergy symptoms in pediatric patients with seasonal allergic rhinitis (SAR)1*†

Pediatric clinical data Banner Image

REACTINE® 5 mg improved SAR symptoms as measured by mean disease severity scores in children ages 2–61* 

Global evaluation of rhinitis by investigators at Week 21 

Based on main effects models for intent-to-treat population

Global evaluation of rhinitis by investigators. Frequency distribution of response (%). ‡P<0.05.  
Adapted from Allegra, et al. 

  • Improvement in Mean Disease Severity scores after 1 week of treatment was not statistically significant (P = 0.064) compared to placebo  

  • Improvement in Mean Disease Severity scores at the end of treatment (Week 2) was significantly greater in the REACTINE® group than the placebo group (P = 0.04) 

  • Global evaluation of rhinitis at the end of treatment also showed improvement which was greater with REACTINE® (P = 0.039) and classified as good or excellent in 34 (63%) of patients compared with 24 (45.3%) on placebo 

REACTINE® 10 mg improved SAR symptoms as measured by total symptom severity scores (TSS) in children ages 6–112†

Mean change from baseline in total symptom severity scores (TSS)2

Based on main effects models on intent-to-treat population

Total symptom severity scores (TSS). Change from baseline during 4 weeks of treatment. Mean = adjusted mean change from baseline TSS over all 4 weeks of treatment. §Statistically significant differences between REACTINE® 10 mg and placebo (P ≤ 0.05). 
Adapted from Pearlman, et al. 

  • Improvement in Total Symptom Severity scores at Week 2 and Week 3 of treatment was significantly greater in the REACTINE® 10 mg group than the placebo group (P ≤ 0.05)  

  • There were no statistically significant differences from placebo for nasal discharge, conjunctivitis, and nasal congestion 

For children over age 6, the recommended dosing is 10 mg REACTINE®. For children under age 6, the recommended dosing is 5 mg REACTINE® 

*Randomized, placebo-controlled, multi-centre, double-blind, parallel group design study of children ages 2 to 6 years (N=107) with SAR during a 2-week period. 

†Randomized, double-blind, placebo-controlled, study of children ages 6 to 11 years (N=209) with SAR during a 4-week period. 

References 

1. Allegra L, Paupe J, Wiesman HG, & Baelde, Y. Cetirizine for seasonal allergic rhinitis in children aged 2–6 years. Pediatr Allergy Immunol. 1993;4(3):157–161.  

2. Pearlman, DS, Lumry, WR, Winder, JA, & Noonan, MJ. Once-daily cetirizine effective in the treatment of seasonal allergic rhinitis in children aged 6 to 11 years: A randomized, double-blind, placebo-controlled study. Clin Pediatr. 1998;26:209.