Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Chronic Cough

Treatments

Drug: Gefapixant

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04193202

MK-7264-043 (Other Identifier)

2019-002308-42 (EudraCT Number)

7264-043

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.

Enrollment

419 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chest radiograph or CT thorax (within 1 year 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 subinvestigator
Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for <12 months prior to the screening visit (<14 months after onset of cough symptoms)
Has a diagnosis of refractory chronic cough or unexplained chronic cough
Female participants are not pregnant, not breastfeeding, not of childbearing potential, or agree to follow contraceptive guidance

Exclusion criteria

Is a current smoker
Has given up smoking within 12 months of screening
Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
Has a history of chronic bronchitis, defined as cough that produces >1 tablespoon of phlegm, that occurs every day for at least 3 months in a row
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer
Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs
Has a known allergy to gefapixant or its excipients
Has donated or lost ≥1 unit (~300 mL) of blood within 8 weeks prior to first dose of gefapixant
Has previously received gefapixant
Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study