Safety and Efficacy of AL-53817 Nasal Spray Solution
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|ClinicalTrials.gov Identifier: NCT01454505|
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Nasal Allergies Allergies||Drug: AL-53817 nasal spray solution Other: Vehicle nasal spray||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety and Efficacy of AL-53817 Nasal Spray Solution in Ragweed Sensitive Subjects in an Environmental Exposure Chamber (EEC)|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: Stage B/AL-53817
Stage B: AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
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.
Placebo Comparator: Stage B/Vehicle
Stage B: Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
Other: Vehicle nasal spray
Inactive ingredients used as placebo comparator during Stage A and Stage B.
- Number of Adverse Events in Stage A [ Time Frame: Day 1 ]Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.
- Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5 [ Time Frame: Baseline (pretreatment), 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.
- Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5 [ Time Frame: Baseline (pretreatment), 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454505
|United States, Texas|
|Alcon Call Center for Trial Locations|
|Fort Worth, Texas, United States, 76134|