Phase 2
Completed N=24
An 8-Week Refractory Chronic Cough Study (MK-7264-021)
Source: ClinicalTrials.gov NCT02612623 ↗Enrolled (actual)
24
Serious AEs
4.4%
Results posted
Nov 2019
Primary outcomePrimary: Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment. — -7.5; -16.9; -18.5; 0.3 Coughs/hour
Summary
This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.
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 | — |
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
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. Informational only — not medical advice.