Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Cetirizine HCl Syrup vs. Loratadine Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)
Condition: Allergic Rhinitis; Hay Fever; SAR; Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl
      syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11
      years old.
    

Detailed description: 
      This was a multi-center, randomized, double-blind, parallel-group, placebo-controlled, double
      dummy study of children with SAR conducted during the Spring tree and grass allergy season.
      Subjects qualified for randomization if the diary cards included (1) symptom scores of ≥2 for
      at least 2 of the following 4 rhinoconjunctivitis symptoms on 4 or more days: sneezing, runny
      nose, itchy eyes, and watery eyes; and (2) a total rhinoconjunctivitis (or Total Symptom
      Severity Complex [TSSC]) score of ≥5 on any 4 days. The TSSC score was expressed as the sum
      of the 4 individual symptoms scores recorded in the daily diary cards for the following
      symptoms: sneezing, runny nose, itchy eyes, and watery eyes.

      Subjects were randomized to receive 1 of 3 treatments in a double-blind fashion using a 1:1:1
      allocation ratio: cetirizine HCl syrup and placebo loratadine syrup; loratadine syrup and
      placebo cetirizine HCl syrup; or cetirizine placebo syrup and loratadine placebo syrup.

      Number of Subjects (Planned and Analyzed): 1100 planned; 1536 screened; 683 randomized: 231
      (33.8%) randomized to the cetirizine HCl treatment group, 221 (32.4%) to the loratadine
      treatment group, and 231 (33.8%) to the placebo treatment group.

      Test Product and Reference Therapy: Subjects randomized to receive cetirizine HCl syrup also
      received placebo syrup; subjects randomized to receive loratadine syrup also received placebo
      syrup; and both placebo syrups were received by subjects randomized to receive placebo.

      Duration of Double-Blind Treatment: 2 weeks.

      Safety measures included the incidence and severity of treatment-emergent adverse events
      (AEs), vital signs, concomitant medications, and physical examination findings. Clinical
      laboratory evaluation was not required for this study.

      Statistical Methods: All statistical tests related to treatment effect were 2-sided, and
      statistical significance was declared at the 0.05 probability level. Least squares means
      (LSMeans) were used to estimate treatment effect. Populations analyzed included the Full
      Analysis (intent-to-treat [ITT]) Set (FAS), Per-Protocol Set (PPS), Safety-Analyzable Set,
      and All-Screened Analysis Set. Demographic and baseline data for all subjects in the
      Safety-Analyzable Set were summarized and listed. The effects of treatment at the Overall and
      all other analysis Time Points were assessed using ANCOVA models. The main effects model
      contained terms for treatment and Investigator site, with baseline TSSC value as a covariate.
      The LSMeans and standard errors were based on the main effects model. Methods of analysis of
      secondary efficacy data included analysis of covariance (ANCOVA) models and
      Cochran-Mantel-Haenszel (CMH) row mean scores tests. Analysis of drug safety included the
      incidence of treatment-emergent AEs (TEAE), concomitant medications, vital signs, and
      physical examination findings for the Safety-Analyzable Set.
    

Intervention name(s): Cetirizine; Loratadine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Cetirizine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks; Loratadine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks; Placebo syrup once daily before 10:00 AM for 2 weeks
Other intervention name(s): ZYRTEC; CLARITIN
Intervention MeSH terms: Cetirizine; Loratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: SAR; seasonal allergic rhinitis; hay fever; seasonal allergic rhinoconjunctivitis