NCT01454505

Safety and Efficacy of AL-53817 Nasal Spray Solution

Safety and Efficacy of AL-53817 Nasal Spray Solution in Ragweed Sensitive Subjects in an Environmental Exposure Chamber (EEC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Nasal Allergies
• Allergies

Interventions

Type	Name	Description
DRUG	AL-53817 nasal spray solution	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.
OTHER	Vehicle nasal spray	Inactive ingredients used as placebo comparator during Stage A and Stage B.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-10-19
• Last updated: 2013-05-20
• Results posted: 2013-05-20

Locations

1 site across 1 country: United States