Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)
Condition: Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy
MeSH terms: Rhinitis; Conjunctivitis
Intervention: Placebo; SCH 697243; Loratadine Syrup 1 mg/mL Rescue Treatment; Loratadine 10 mg Rescue Treatment; Olopatadine 0.1% Rescue Treatment; Mometasone furoate 50 mcg Rescue Treatment; Albuterol 108 mcg Rescue Treatment; Fluticasone 44 mcg Rescue Treatment; Prednisone 5 mg Rescue Treatment
Intervention description: Placebo sublingual tablet, once daily; Grass sublingual tablet, once daily; Loratadine Syrup 1 mg/mL was dosed orally once daily at a dose of 5 mg for children aged 5 to <6 years of age and at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4.; Loratadine 10 mg RediTabs tablets were dosed orally once daily at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4.; Olopatadine hydrochloride 0.1% ophthalmic solution was dosed intraocularly at a dose of 1 drop in each affected eye twice daily, in addition to loratadine, as rescue medication for participants with persistent eye symptoms due to rhinoconjunctivitis.; Mometasone furoate monohydrate nasal spray 50 mcg was dosed intranasally at a dose of one spray in each nostril once daily for participants aged 5 to <12 years and a dose of 2 sprays in each nostril once daily for participants aged 12 to <18 years as rescue medication for nasal symptoms of rhinoconjunctivitis among participants with a total symptom score of ≥4 despite loratadine and mometasone furoate nasal spray.; Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administered via inhalation at a dose of 2 inhalations every 4 to 6 hours as rescue medication among participants aged 5 to <18 years with asthma symptoms .; Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of 2 inhalations twice daily among participants aged 12 to <18 years up to a maximum dose of 10 inhalations twice daily, in combination with albuterol, among participants with ≥4 albuterol sulfate inhalations/day for 2 days as rescue medication for nocturnal asthma or shortness of breath.; Prednisone tablet 5 mg was administered orally at a dose of 1 mg/kg/day once daily up to a maximum of 50 mg/day on Day 1, and at a dose of 0.5 mg/kg/day once daily up to a maximum of 25 mg/day on Days 2, 3, 5, and 7 as rescue medication for asthma exacerbation at the discretion of the investigator.
Intervention MeSH terms: Fluticasone; Mometasone Furoate; Loratadine; Olopatadine Hydrochloride; Prednisone; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 345.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: rhinoconjunctivitis; rhinitis; conjunctivitis; allergy; allergen; immunotherapy

Summary:

      The purpose of the study is to investigate the efficacy and safety of a grass sublingual
      tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis
      with or without asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be 5 to <18 years of age, of either sex, and of any race.

          -  Participant must have a clinical history of significant allergic rhinoconjunctivitis
             to grass (with or without asthma) diagnosed by a physician and have received treatment
             for their disease during the previous GPS.

          -  Participant must have a positive skin prick test response (average wheal diameter >=5
             mm larger than the saline control after 15 to 20 minutes) to Phleum pratense at the
             Screening Visit.

          -  Participant must have positive specific IgE against Phleum pratense (>= IgE Class 2)
             at the Screening Visit.

          -  Participant must have an FEV1 >=70% of predicted value at the Screening Visit.

          -  A participant's safety laboratory tests and vital signs conducted at the Screening
             Visit must be within normal limits or clinically acceptable to the
             investigator/sponsor.

          -  A participant (and/or parent/guardian for subjects under the age of legal consent or
             who otherwise are unable to provide independent consent) must be willing to give
             written informed consent/assent and be able to adhere to dose and visit schedules.

          -  Female participants of childbearing potential must be using a medically acceptable and
             adequate form of birth control. These include:

               -  hormonal contraceptives as prescribed by a physician (oral, hormonal vaginal
                  ring, hormonal implant or depot injectable);

               -  medically prescribed intra-uterine device;

               -  medically prescribed topically-applied transdermal contraceptive patch;

               -  double-barrier method (eg, condom in combination with a spermicide); vasectomy
                  and tubal ligation should each be considered as single barrier.

          -  Female participants of childbearing potential should be counseled in the appropriate
             use of birth control while in the study. Female participants who are not currently
             sexually active must agree and consent to use one of the above-mentioned methods if
             they become sexually active while participating in the study.

          -  Female participants of childbearing potential must have a negative urine pregnancy
             test at the Screening Visit in order to be considered eligible for enrollment.

        Exclusion Criteria:

          -  Participant with a clinical history of symptomatic seasonal allergic rhinitis and/or
             asthma, having received regular medications due to another allergen during or
             potentially overlapping the GPS.

          -  Participant with a clinical history of significant symptomatic perennial allergic
             rhinitis and/or asthma having received regular medication due to an allergen to which
             the participant is regularly exposed.

          -  Participant with sufficient pre-seasonal data in the observational phase will not be
             eligible to continue in the treatment phase if the participant: 1) does not experience
             an increase in rhinoconjunctivitis symptom score of equal to or greater than 4 above
             the pre-seasonal average symptom score for at least 2 days, 2) does not use allergy
             rescue medication for at least 2 days, during the observational phase Year 1 2008 GPS.

          -  Participant has received an immunosuppressive treatment within 3 months prior to the
             Screening Visit (except steroids for allergic and asthma symptoms).

          -  Participant with a clinical history of severe asthma.

          -  Participant with history of anaphylaxis with cardiorespiratory symptoms.

          -  Participant with history of self-injectable epinephrine use.

          -  Participant with a history of chronic urticaria and angioedema.

          -  Participant with clinical history of chronic sinusitis during the 2 years prior to the
             Screening Visit.

          -  Participant with current severe atopic dermatitis.

          -  Female participants who are breast-feeding, pregnant, or intending to become pregnant.

          -  Participant who has had previous treatment by immunotherapy with grass pollen allergen
             or any other allergen within the 5 years prior to the Screening Visit.

          -  Participant with a known history of allergy, hypersensitivity or intolerance to the
             ingredients of the IMP (except for Phleum pratense), rescue medications, or
             self-injectable epinephrine.

          -  Participant with any clinically significant condition or situation, other than the
             condition being studied that, in the opinion of the investigator, would interfere with
             the study evaluations or optimal participation in the study. Specific examples include
             but are not limited to hypertension being treated with beta blockers, coronary artery
             disease, arrhythmia, stroke, ocular conditions requiring topical beta blockers, any
             condition requiring the use of beta blockers.

          -  Participant who has used any investigational drugs within 30 days of the Screening
             Visit.

          -  Participant who is participating in any other clinical study.

          -  Participant who is a family member of the investigational study staff conducting this
             study.

          -  Participant who is unable to meet medication washout requirements as listed in the
             protocol.

          -  Participant who is unlikely to be able to complete the trial, for any reason, or
             likely to travel for extended periods of time during the GPS, which in the opinion of
             the investigator will compromise the data.

          -  Participant with a clinically significant abnormal vital sign or laboratory value that
             would preclude participation in the study.

          -  A participant participating in this study may not participate in this same study at
             another investigational site.

          -  A participant must not be randomized into this study more than once.

          -  Participant who is unable to or will not comply with the use of self-injectable
             epinephrine.

          -  Participants who may be at greater risk of developing adverse reactions after
             epinephrine administration.