Phase 3
N=161
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension
Chronic Cough
Bottom Line
View on ClinicalTrials.gov: NCT04525885 ↗Enrolled (actual)
161
Serious AEs
6.3%
Results posted
Oct 2023
Primary outcome: Primary: Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24 — 0.47; 0.51 Ratio — p=0.713
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gefapixant 45 mg twice daily (BID) (Drug); Gefapixant 15 mg BID (Drug); Placebo (Drug); Gefapixant 45 mg BID (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24 |
0.47; 0.51 | 0.713 |
| PRIMARY Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up |
54; 20; 58 | — |
| PRIMARY Percentage of Participants Who Discontinued Treatment Due to an AE |
0; 1; 5 | — |
| SECONDARY Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline |
0.46; 0.51 | 0.628 |
| SECONDARY Percentage of Participants With a ≥1.3-point Increase From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24 |
68.4; 67.5 | 0.917 |
| SECONDARY Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Coughs Per Hour at Week 24 |
54.6; 50.6 | 0.687 |
| SECONDARY Percentage of Participants With ≥1.3-point Reduction From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24 |
58.7; 61.1 | — |
| SECONDARY Percentage of Participants With ≥2.7-point Reduction From Baseline of Mean Weekly CSD Total Score at Week 24 |
23.9; 37.8 | — |
| SECONDARY Percentage of Participants With a ≥30 mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24 |
23.0; 24.9 | — |
Summary
The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period. It is hypothesized that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.
Eligibility Criteria
Inclusion Criteria
- Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
- Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
- Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
- Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)
Exclusion Criteria
- Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
- Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
- Has a history of chronic bronchitis
- Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
- Has an estimated glomerular filtration rate (eGFR) =1 unit of blood within 8 weeks prior to the first dose of gefapixant
- Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study
Data sourced from ClinicalTrials.gov (NCT04525885). 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.