Phase 3
Completed N=1,317
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)
Source: ClinicalTrials.gov NCT03449147 ↗Enrolled (actual)
1,317
Serious AEs
5.2%
Results posted
Sep 2021
Primary outcomePrimary: Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline — 0.43; 0.43; 0.37 Ratio — p=0.875
◆ Published Evidence
Highly cited
313citations · ~78 / year
Efficacy and safety of gefapixant, a P2X<sub>3</sub> receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials.
Summary
The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.
Linked Publications (2)
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Efficacy and safety of gefapixant, a P2X<sub>3</sub> receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials.
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Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline |
0.43; 0.43; 0.37 | 0.875 |
| PRIMARY Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up |
349; 373; 399 | — |
| PRIMARY Number of Participants Who Discontinued a Study Drug Due to an AE |
25; 40; 100 | — |
| SECONDARY Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline |
0.42; 0.41; 0.36 | 0.677 |
| SECONDARY Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24 |
70.1; 75.9; 76.8 | 0.077 |
| SECONDARY Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24 |
66.9; 67.4; 72.9 | 0.872 |
| SECONDARY Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24 |
69.1; 74.8; 77.1 | — |
| SECONDARY Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24 |
41.0; 46.6; 55.2 | — |
| SECONDARY Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24 |
40.9; 51.4; 53.3 | — |
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) <30 mL/min/1.73 m^2 at Screening OR an eGFR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal function
- Has a history of malignancy ≤5 years
- Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
- Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
- Has a known allergy/sensitivity or contraindication to gefapixant
- Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
- Has previously received gefapixant
- Currently participating in or has participated in an interventional clinical study within 30 days of screening
Data sourced from ClinicalTrials.gov (NCT03449147) and the linked publication. 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.