To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on placebo.
This double-blind, placebo-controlled study will evaluate the efficacy and safety of STAHIST vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two years. The study will take place in two sites, Louisville, KY and South Bend, IN. SAR symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
The South Bend Clinic
South Bend, Indiana, United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, United States
Total Symptom Scores(TSS)reported and compared between the two study arms
TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip
Time frame: Twice daily over the 2 week study period
Adverse events--report and assess
Any/all adverse events will be recorded and scored, reported, evaluated, and results will be clinically and statistically compared between the placebo and active drug arms.
Time frame: Continuous over the two week study period
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