Clinical trial NCT02612623: An 8-Week Refractory Chronic Cough Study (MK-7264-021)
Official title: A Randomized, Parallel, Double-Blind Study to Assess the Efficacy and Tolerability of AF-219 in Subjects With Refractory Chronic Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Chronic Cough
Lead sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.
timeFrame: Baseline and Week 8 (Day 56)
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Afferent Investigative Site
state: California
city: San Jose
country: United States
facility: Afferent Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Afferent Investigative Site
state: Colorado
city: Largo
country: United States
facility: Afferent Investigative Site
state: Florida
city: Charlotte
country: United States
facility: Afferent Investigative Site
state: North Carolina
city: Tulsa
country: United States
facility: Afferent Investigative Site
state: Oklahoma
city: Dallas
country: United States
facility: Afferent Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Afferent Investigative Site
state: Texas
city: Bellevue
country: United States
facility: Afferent Investigative Site
state: Washington
city: Greenfield
country: United States
facility: Afferent Investigative Site
state: Wisconsin
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: