Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT01454505
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
2011-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of AL-53817 Nasal Spray Solution
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
Safety and Efficacy of AL-53817 Nasal Spray Solution in Ragweed Sensitive Subjects in an Environmental Exposure Chamber (EEC)
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: