Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064.
The purpose of this study is to determine the safety and effectiveness of CYR-064 in a randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR064. The study will take approximately 32 weeks which will include a 4-week screening period to evaluate if participants are right for the Study, followed by a 24-week Treatment Period, and a 1 week follow up after participants have completed the Study. About 150 subjects will participate in this study in about 25 research sites in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
CYR-064 is a nasal solution.
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
ENTAAFL
Boca Raton, Florida, United States
ENTAAFL
Plantation, Florida, United States
Primary Outcome - Safety and Tolerability
The count and percentage of patients reporting AEs, SAEs, and SUSARs will be summarized overall, by System Organ Class, Preferred Term within the System Organ Class, maximum severity, and relationship to study drug. All other safety parameters, including clinical laboratory values through blood draws, will be summarized using descriptive statistics for continuous variables and counts and percentages for categorical variables. All changes in nasal mucosal appearance will be noted.
Time frame: Approximately 32 weeks
Secondary Outcome-improvement on NRS-11 Smell-PRO
Improvement in patient reported NRS-11 Smell-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.
Time frame: Approximately 24 weeks
Secondary Outcome-improvement on NRS-11 Taste-PRO
Improvement in patient reported NRS-11 Taste-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.
Time frame: Approximately 24 weeks
Secondary Outcome-Mean Change in NRS-11 Smell-PRO
Mean Change in NRS-11 Smell-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 24
Time frame: Approximately 24 weeks
Secondary Outcome-Mean Change in NRS-11 Taste-PRO
Mean Change in NRS-11 Taste-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 2
Time frame: Approximately 24 weeks
Change in Visual Rating Scale (VRS) scores
Change in Visual Rating Scale (VRS) scores in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24. * VRS high dose versus placebo * VRS low dose versus placebo * VRS low and high dose combined versus placebo
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ENTAAFL
Port Saint Lucie, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
KU Medical Center-University of Kansas
Kansas City, Kansas, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Centers for Advanced ENT
Baltimore, Maryland, United States
Specialty Physician Associates
Bethlehem, Pennsylvania, United States
...and 4 more locations
Time frame: Approximately 24 weeks