Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)
Condition: Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy
MeSH terms: Rhinitis; Conjunctivitis
Study type: Interventional
Phase: Phase 3

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

Detailed description: 
      This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study in
      participants 18 to 65 years of age, of either sex, and of any race with a history of grass
      pollen induced rhinoconjunctivitis with or without asthma. While receiving treatment,
      participants will receive either grass sublingual tablet or placebo. Open-label rescue
      medications for the hinoconjunctivitis and asthma symptoms will be provided. Participants
      will visit the study site for at least 12 visits. A total of 10 allergic symptoms, 6
      rhinoconjunctivitis and 4 lung symptoms, will be recorded daily on an electronic diary by the
      participant.

      The start and end of the grass pollen season (GPS) was determined based on the regional grass
      pollen count, and lasted up to 162 days. For each region, the GPS is defined as the first day
      of 3 consecutive recorded days with a grass pollen count of ≥ 10 grains/m^3, to the last day
      of the last occurrence of 3 consecutive recorded days with a grass pollen count ≥ 10
      grains/m^3, inclusively.
    

Intervention name(s): 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 type(s): Drug; Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Phleum pratense extract; Claritin; Pantanol; Nasonex; Deltasone; Meticorten; Orasone; Prednicen-M; Prednicot; Sterapred; Sterapred DS; Proventil; Ventolin; Volmax; Vospire; Flonase; Deltasone; Meticorten; Orasone; Prednicen-M; Prednicot; Sterapred; Sterapred DS
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Loratadine; Olopatadine Hydrochloride; Prednisone; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rhinoconjunctivitis; rhinitis; conjunctivitis; allergy; allergen; immunotherapy