Clinical trial NCT02478398 (phase 3, status: completed)
Conditions: rhinitis, allergic, seasonal
ICD codes: J30.2
Drugs: self-injectable epinephrine, albuterol/salbutamol, loratadine, olopatadine, mometasone furoate monohydrate
SMILES: CNC[C@H](O)C1=CC(O)=C(O)C=C1, CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1, CCOC(=O)N1CCC(CC1)=C1C2=C(CCC3=C1N=CC=C3)C=C(Cl)C=C2, CN(C)CC\C=C1\C2=CC=CC=C2COC2=C1C=C(CC(O)=O)C=C2, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Is between the ages of 4 and 17 years (inclusive) at enrollment in this study and is
             at least 5 years old at randomization

          -  Has a clinical history of significant ragweed pollen-induced allergic
             rhinitis/rhinoconjunctivitis of ≥1 year (at least 1 season for ages 4 to 6 years) or
             ≥2 years (at least 2 seasons for ages 7 to 17 years) duration diagnosed by a physician
             (with or without asthma) and have received treatment for the condition during the
             previous ragweed season

          -  If female, agrees to remain abstinent or use (or have their partner use) an acceptable
             method of birth control within the projected duration of the study.

        Exclusion Criteria:

          -  Has a clinical history of symptomatic seasonal allergic rhinitis (and/or asthma) due
             to another allergen, which has required regular medication during, or potentially
             overlapping, the ragweed season

          -  Has a clinical history of significant symptomatic perennial allergic rhinitis and/or
             asthma due to an allergen to which the subject is regularly exposed during the ragweed
             season which would interfere with assessment of the treatment effect

          -  Has any nasal condition that could confound the efficacy or safety assessments (e.g.,
             nasal polyposis).

          -  Has asthma requiring high daily doses of inhaled corticosteroids within the 6 months
             prior to the Screening visit

          -  Is either >7 years old and cannot perform reproducible FEV1 maneuvers despite
             coaching; OR is ≤7 years old and cannot perform reproducible FEV1 maneuvers despite
             coaching and has current symptoms of asthma characterized by recurrent episodes of
             wheezing, or episodes of cough, wheeze, difficulty in breathing, or chest tightness

          -  Has severe, unstable, or uncontrolled asthma, as judged by the clinical investigator,
             or has experienced a life-threatening asthma attack or an occurrence of any clinical
             deterioration of asthma that resulted in emergency treatment, hospitalization due to
             asthma, or treatment with systemic corticosteroids (but allowing short-acting beta
             agonists) at any time within the last 3 months prior to the Screening or Randomization
             visits

          -  Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy,
             unknown cause, or inhalant allergen

          -  Has a diagnosis of eosinophilic esophagitis

          -  Has a history of chronic urticaria and/or chronic angioedema

          -  Has a clinical history of chronic sinusitis during the 2 years prior to the Screening
             or Randomization visits

          -  Has current severe atopic dermatitis

          -  Has a history of allergy, hypersensitivity, or intolerance to the ingredients of the
             study drug (except for Ambrosia artemisiifolia), rescue medications, or
             self-injectable epinephrine

          -  Has previously received short ragweed pollen allergen extract

          -  Has previously been randomized into this study

          -  Is participating in any other clinical study or plans to participate in another
             clinical study during the duration of this study