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

Refractory Chronic Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612623
• Other study ID #: 7264-021
• Secondary ID: AF219-021MK-7264
• Status: Completed
• Phase: Phase 2
• Start date: December 17, 2015
• Est. completion date: May 18, 2016

Study information

• Verified date: November 2019
• Source: Afferent Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 18, 2016
• Est. primary completion date: May 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Refractory Chronic Cough

Intervention

Drug:
• Gefapixant
Gefapixant tablets administered by mouth twice daily for 8 weeks
• Placebo (for gefapixant)
Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Afferent Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)