The purpose of this study was to determine the maximum tolerated dose of AL-53817 (Stage A) and evaluate the safety and efficacy of AL-53817 for the treatment of allergic rhinitis (Stage B).
Stage A was a 1-day, single ascending dose study utilizing 7 separate cohorts of unique subjects (healthy normal volunteers). Each cohort was administered a different dose of AL-53817 Nasal Spray Solution in order to determine the maximum tolerated dose (MTD). In Stage B, 2 different cohorts of unique, ragweed-sensitive subjects were administered the MTD for up to 5 days twice a day to determine the safety and efficacy of AL-53817 Nasal Spray Solution for the treatment of allergic rhinitis. Subjects were required to meet minimum allergic rhinitis scores at two qualifying EEC visits to participate in the study. Subjects were continually housed in clinic during the 5-day treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Active ingredients administered in 1 of 3 concentrations during Stage A to determine maximum tolerated dose (MTD), and administered at maximum tolerated dose during Stage B.
Inactive ingredients used as placebo comparator during Stage A and Stage B.
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
Number of Adverse Events in Stage A
Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.
Time frame: Day 1
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
Time frame: Baseline (pretreatment), Day 5
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
Stage B: Nasal symptoms were assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. TNSS score (0-12) was a sum of scores for nasal congestion, sneezing, itchy nose, and runny nose scores, each individually assessed on a 0 to 3 scale, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
Time frame: Baseline (pretreatment), Day 5
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