Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)
Condition: Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy
MeSH terms: Rhinitis; Conjunctivitis
Intervention: Placebo; SCH 697243; Loratadine 10 mg Rescue Treatment; Olopatadine 0.1% Rescue Treatment; Mometasone 50 mcg Rescue Treatment; Prednisone 5 mg Rescue Treatment; Albuterol sulfate 108 mcg; Fluticasone propionate 44 mcg; Prednisone 5 mg
Intervention description: Placebo sublingual tablet; SCH 697243 (2800 Bioequivalent Allergen Units [BAU] of Phleum pratense extract, containing approximately 15 mcg Phl p 5), administered sublingually once daily.; Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication among participants with a total symptom score ≥ 4 during the GPS.; Olopatadine hydrochloride 0.1% ophthalmic solution was administered intraocularly at a dose of 1 drop in each affected eye twice daily as rescue medication for rhinoconjunctivitis, as needed.; Mometasone furoate monohydrate nasal spray 50 mcg was admininstered intranasally at a dose of 2 sprays in each nostril once daily as rescue medication for rhinoconjunctivitis, as needed.; Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day
(maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for rhinoconjunctivitis among participants with a total symptom score of ≥ 4 despite treatment with loratadine and mometasone furoate nasal spray.; Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administed via inhalation at a dose of 2 inhalations every 4 to 6 hours, as needed, as rescue medication for asthma.; Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of two inhalations twice daily, to a maximum dose of 10 inhalations twice daily, as rescue medication for asthma among participants utilizing four or more albuterol sulfate inhalations/day for 2 days for nocturnal asthma or shortness of breath.; Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day (maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for asthma at the discretion of the investigator for the treatment of asthma exacerbation.
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Loratadine; Olopatadine Hydrochloride; Prednisone; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 439.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: rhinoconjunctivitis; rhinitis; conjunctivitis; allergy; allergen; immunotherapy

Summary:

      This purpose of this study is to determine the efficacy and safety of a grass sublingual
      (under-the-tongue) tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be 18 to 65 years of age, of either sex, and of any race.

          -  Participants 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.

          -  Participants 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.

          -  Participants must be positive for specific IgE against Phleum pratense (>=IgE Class 2)
             at the Screening Visit.

          -  Participants must have an FEV1 >=70% of predicted value at the Screening Visit.

          -  Participants' safety laboratory tests, vital signs and ECG conducted at the Screening
             Visit must be within normal limits or clinically acceptable to the
             investigator/sponsor.

          -  Participant must be willing to give written informed consent 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:

          -  Participants 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.

          -  Participants with a clinical history of significant symptomatic perennial allergic
             rhinitis and/or asthma having received regular medication due to an allergen to which
             the subject is regularly exposed.

          -  Participants with sufficient pre-seasonal data in the observational phase will not be
             eligible to continue in the treatment phase if the subject: 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.

          -  Participants that received an immunosuppressive treatment within 3 months prior to the
             Screening Visit (except steroids for allergic and asthma symptoms).

          -  Participants with a clinical history of severe asthma.

          -  Participants with history of anaphylaxis with cardiorespiratory symptoms.

          -  Participants with a history of self-injectable epinephrine use.

          -  Participants with a history of chronic urticaria and angioedema.

          -  Participants with clinical history of chronic sinusitis during the 2 years prior to
             the Screening Visit.

          -  Participants with current severe atopic dermatitis.

          -  Female participants who are breast-feeding, pregnant, or intending to become pregnant.

          -  Participatns who have had previous treatment by immunotherapy with grass pollen
             allergen or any other allergen within the 5 years prior to the Screening Visit.

          -  Participants with a known history of allergy, hypersensitivity or intolerance to the
             ingredients of the investigational medicinal products (except for Phleum pratense),
             rescue medications, or self-injectable epinephrine.

          -  Participants 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.

          -  Participants that have used any investigational drugs within 30 days of the Screening
             Visit.

          -  Participants that are participating in any other clinical study.

          -  Participants that are a family member of the investigational study staff conducting
             this study.

          -  Participants that are unable to meet medication washout requirements as listed in the
             protocol.

          -  Participants that are 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.

          -  Participants with a clinically significant abnormal vital sign or laboratory value
             that would preclude participation in the study.

          -  Participants participating in this study may not participate in this same study at
             another investigational site.

          -  Participants must not be randomized into this study more than once.

          -  Participants who are unable to or will not comply with the use of self-injectable
             epinephrine.

          -  Participants that may be at greater risk of developing adverse reactions after
             epinephrine administration.