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Table 1 Eligibility criteria

From: Relieving nasal congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate nasal spray

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

 
  1. AR, allergic rhinitis; PAR, perennial allergic rhinitis; SAR, seasonal allergic rhinitis; TNSS, total nasal symptom score.