This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Gefapixant tablets administered by mouth twice daily for 8 weeks
Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
Afferent Investigative Site
Mission Viejo, California, United States
Afferent Investigative Site
San Jose, California, United States
Afferent Investigative Site
Colorado Springs, Colorado, United States
Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.
Time frame: Baseline and Week 8 (Day 56)
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Afferent Investigative Site
Largo, Florida, United States
Afferent Investigative Site
Charlotte, North Carolina, United States
Afferent Investigative Site
Tulsa, Oklahoma, United States
Afferent Investigative Site
Dallas, Texas, United States
Afferent Investigative Site
San Antonio, Texas, United States
Afferent Investigative Site
Bellevue, Washington, United States
Afferent Investigative Site
Greenfield, Wisconsin, United States