An 8-Week Refractory Chronic Cough Study (MK-7264-021)

A Randomized, Parallel, Double-Blind Study to Assess the Efficacy and Tolerability of AF-219 in Subjects With Refractory Chronic Cough

This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.

Study Overview

• Status: Completed
• Conditions: Refractory Chronic Cough
• Intervention / Treatment: Drug: Gefapixant; Drug: Placebo (for gefapixant)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States
      • Afferent Investigative Site
    • San Jose, California, United States
      • Afferent Investigative Site
  • Colorado
    • Colorado Springs, Colorado, United States
      • Afferent Investigative Site
  • Florida
    • Largo, Florida, United States
      • Afferent Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States
      • Afferent Investigative Site
  • Oklahoma
    • Tulsa, Oklahoma, United States
      • Afferent Investigative Site
  • Texas
    • Dallas, Texas, United States
      • Afferent Investigative Site
    • San Antonio, Texas, United States
      • Afferent Investigative Site
  • Washington
    • Bellevue, Washington, United States
      • Afferent Investigative Site
  • Wisconsin
    • Greenfield, Wisconsin, United States
      • Afferent Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Women and Men between 18 and 80 years of age inclusive
• Have refractory chronic cough
• Women of child-bearing potential must use 2 forms of acceptable birth control
• Have provided written informed consent.
• Are willing and able to comply with all aspects of the protocol.

Exclusion Criteria:

• Current smoker
• Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%
• History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
• History of opioid use within 1 week of the Baseline Visit
• Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
• History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with <3 excised basal cell carcinomas)
• Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
• Significantly abnormal laboratory tests at Screening
• Clinically significant abnormal electrocardiogram (ECG)
• Pregnant or Breastfeeding
• Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gefapixant 15 mg twice daily; Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Drug: Gefapixant; Gefapixant tablets administered by mouth twice daily for 8 weeks; Other Names: AF-219; MK-7264
EXPERIMENTAL: Gefapixant 30 mg twice daily; Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Drug: Gefapixant; Gefapixant tablets administered by mouth twice daily for 8 weeks; Other Names: AF-219; MK-7264
EXPERIMENTAL: Gefapixant 50 mg twice daily; One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks	Drug: Gefapixant; Gefapixant tablets administered by mouth twice daily for 8 weeks; Other Names: AF-219; MK-7264
EXPERIMENTAL: Placebo to match gefapixant; Matching placebo tablets administered by mouth twice daily for 8 weeks	Drug: Placebo (for gefapixant); Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 8 (Day 56)

Collaborators and Investigators

• Sponsor: Afferent Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2015
• Primary Completion (ACTUAL): May 4, 2016
• Study Completion (ACTUAL): May 18, 2016

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (ESTIMATE): November 24, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 7264-021; AF219-021 (OTHER: Afferent Pharmaceuticals); MK-7264-021 (OTHER: Merck Protocol Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf