The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Unnamed facility
Canton, Ohio, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Combined Score of symptoms and allergy medication
Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication
Time frame: Approximately 66 weeks
Safety of Grass-SPIRE
Measurement of adverse events
Time frame: Approximately 66 weeks
Symptom Scores
Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects
Time frame: Approximately 66 weeks
Rescue Medication Use
Use of allergy medication to help allergy symptoms
Time frame: Approximately 66 weeks
Quality of Life
Assessment of Quality of Life measured by responses to a questionnaire
Time frame: Approximately 66 weeks
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