The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration \>8 weeks after onset of cough symptoms) for \<12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
419
Administered twice daily as an oral tablet of 45 mg
Administered twice daily as a placebo oral tablet matching gefapixant
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated.
Time frame: Baseline, Week 12
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12
Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score is calculated.
Time frame: Baseline, Week 12
Percentage of Participants With One or More Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs is presented.
Time frame: Up to approximately 14 weeks
Percentage of Participants Who Discontinue Study Drug Due to an AE
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE is presented.
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Pulmonary Associates, PA ( Site 0016)
Phoenix, Arizona, United States
Center for Clinical Trials, LLC ( Site 0035)
Paramount, California, United States
Springfield Clinic, LLP ( Site 0018)
Springfield, Illinois, United States
Chesapeake Clinical Research, Inc ( Site 0037)
White Marsh, Maryland, United States
Albuquerque Clinical Trials ( Site 0030)
Albuquerque, New Mexico, United States
Montefiore Einstein Center ( Site 0022)
The Bronx, New York, United States
American Health Research ( Site 0047)
Charlotte, North Carolina, United States
Clinical Research Institute of Southern Oregon, PC ( Site 0028)
Medford, Oregon, United States
Northwest Research Center ( Site 0039)
Portland, Oregon, United States
AAPRI Clinical Research Institute ( Site 0051)
Lincoln, Rhode Island, United States
...and 81 more locations
Time frame: Up to approximately 12 weeks