Phase 3 N=732 Randomized Double-blind Treatment

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)

Chronic Cough

Bottom Line

View on ClinicalTrials.gov: NCT03449134 ↗

Enrolled (actual)

732

Serious AEs

5.7%

Results posted

Jun 2021

Primary outcome: Primary: Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline) — 0.47; 0.48; 0.38 ratio — p=0.041

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Gefapixant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline)	0.47; 0.48; 0.38	0.041 sig
PRIMARY Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up	184; 186; 208	—
PRIMARY Number of Participants Who Discontinued Treatment Due to AEs	14; 15; 51	—
SECONDARY Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline)	0.46; 0.47; 0.38	0.056
SECONDARY Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12	65.9; 66.2; 69.9	0.416
SECONDARY Percentage of Participants (Model-Based) With a ≤ -1.3-point Change From Baseline in Mean Weekly Cough Severity Diary (CSD) Total Score at Week 12	52.4; 62.1; 60.5	—
SECONDARY Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12	28.6; 37.9; 40.1	—
SECONDARY Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12	31.3; 36.7; 41.2	—
SECONDARY Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12	61.3; 68.8; 67.3	—

Summary

The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.

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
Female participants are eligible if not pregnant, not breastfeeding, and either not of childbearing potential, or agree 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
Has forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio 160 mm Hg or diastolic blood pressure >90 mm Hg at Screening
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 or is currently participating in or has participated in an interventional clinical study
Had significantly abnormal laboratory tests at Screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03449134). 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.