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Gefapixant for Chronic Bronchitis

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 14 weeks
Awards & highlights

Summary

This trial is testing a new drug to see if it helps people with a cough that can't be explained and has gone on for more than 8 weeks but less than a year. The main measure of success is whether the cough improves the person's quality of life.

Eligible Conditions
  • Chronic Cough
  • Chronic Bronchitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Secondary outcome measures
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12
Percentage of Participants Who Discontinue Study Drug Due to an AE
Percentage of Participants With One or More Adverse Events (AEs)

Side effects data

From 2022 Phase 3 trial • 376 Patients • NCT04193176
31%
Dysgeusia
19%
Ageusia
8%
Hypogeusia
7%
Headache
5%
Nausea
1%
Rectal fissure
1%
Ankle fracture
1%
Cholecystitis chronic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Gefapixant

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GefapixantExperimental Treatment1 Intervention
Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gefapixant
2017
Completed Phase 3
~2640

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,160 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,687 Total Patients Enrolled
1 Trials studying Chronic Bronchitis
106 Patients Enrolled for Chronic Bronchitis
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,361 Total Patients Enrolled
~80 spots leftby Sep 2025
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