An 8-Week Refractory Chronic Cough Stud… | Clinical Trial

Key information

Conditions

Refractory Chronic Cough Chronic Cough Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Afferent Investigative Site, Mission Viejo, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefapixant

Drug

Gefapixant tablets administered by mouth twice daily for 8 weeks

Other names: AF-219, MK-7264

Placebo (for gefapixant)

Drug

Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks

Primary outcomes

Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.

Time frame: Baseline and Week 8 (Day 56)

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.

Sponsors and collaborators

Lead sponsor

Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 24, 2015
Registry last updated: Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed