Allergy Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Adult Subjects With a History of Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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