Phase 2 N=24 Randomized Quadruple-blind Treatment

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

Refractory Chronic Cough

Bottom Line

View on ClinicalTrials.gov: NCT02612623 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Nov 2019

Primary outcome: Primary: Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment. — -7.5; -16.9; -18.5; 0.3 Coughs/hour

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Gefapixant (Drug); Placebo (for gefapixant) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.	-7.5; -16.9; -18.5; 0.3	—

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) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02612623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.