Study 1 (SAR) | Study 2 (PAR) | ||
---|---|---|---|
Inclusion criteria | Exclusion criteria | Inclusion criteria | Exclusion criteria |
Aged 6–11 years, of either sex and any race | Asthma requiring chronic use of inhaled or systemic corticosteroids | Aged 3–11 years (8–11 years in Chile and Sweden), of either sex and any race, with ≥1-year history of PAR requiring over-the-counter or prescription treatment within the year preceding the study | Asthma requiring chronic use of inhaled or systemic corticosteroids |
≥1-year history of SAR that previously required treatment | Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip | Allergic response to ≥1 clinically significant perennial allergen (house dust mite, perennial indoor mold, or animal dander prevalent in the subject’s environment) documented by a positive skin prick test (wheal diameter ≥3 mm larger than diluent control) or intradermal skin test (wheal diameter ≥7 mm larger than diluent control) | History of or current clinically significant sinus infection, chronic purulent postnasal drip, rhinitis medicamentosa, allergies to ≥2 classes of drugs, allergy to corticosteroids, or posterior subcapsular cataracts |
Positive skin test response to an appropriate tree and/or grass seasonal allergen within the last year | Rhinitis medicamentosa | Nasal congestion score ≥2 (indicating a symptom of at least moderate intensity), TNSS ≥5 at both screening and baseline visits | Nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal airflow |
Clinically symptomatic at both screening and baseline; nasal congestion at least moderate (score ≥2) with a total nasal symptom score ≥6 | Upper respiratory tract or sinus infection that required antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection within 7 days prior to screening | Investigator-assessed overall PAR score ≥2 at baseline, and at least moderate rhinorrhea and/or congestion documented in a subject treatment diary for ≥4 of the 7 days prior to baseline | Treatment with inhaled corticosteroids for asthma for ≥2 months within the 12 months prior to enrollment or within 1 month before enrollment or 2 courses of systemic steroids, or any course lasting ≥14 days, within the 12 months preceding enrollment |
Receiving immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least 1 month prior to screening | Free of any clinically significant disease, other than AR, that could interfere with study evaluations |