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

Phase 3

Completed

• Conditions: Chronic Cough
• Interventions: Drug: Gefapixant; Drug: Placebo

• Registration Number: NCT04193202
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Study Start: 2020-05-21
• Primary Completion: 2021-10-19
• Study Completion: 2021-11-03
• Results First Submitted: 2022-09-19
• Results First Submitted QC: 2022-09-19
• Results First Posted: 2022-10-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gefapixant	Gefapixant	Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Placebo	Placebo	Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12	Baseline, Week 12	Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12	Baseline, Week 12	Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score is calculated.
Percentage of Participants With One or More Adverse Events (AEs)	Up to approximately 14 weeks	An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs is presented.
Percentage of Participants Who Discontinue Study Drug Due to an AE	Up to approximately 12 weeks	An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE is presented.

Trial Locations

Locations (91)

Pulmonary Associates, PA ( Site 0016); 🇺🇸 Phoenix, Arizona, United States

Center for Clinical Trials, LLC ( Site 0035); 🇺🇸 Paramount, California, United States

Springfield Clinic, LLP ( Site 0018); 🇺🇸 Springfield, Illinois, United States

Chesapeake Clinical Research, Inc ( Site 0037); 🇺🇸 White Marsh, Maryland, United States

Albuquerque Clinical Trials ( Site 0030); 🇺🇸 Albuquerque, New Mexico, United States

Montefiore Einstein Center ( Site 0022); 🇺🇸 Bronx, New York, United States

American Health Research ( Site 0047); 🇺🇸 Charlotte, North Carolina, United States

Clinical Research Institute of Southern Oregon, PC ( Site 0028); 🇺🇸 Medford, Oregon, United States

Northwest Research Center ( Site 0039); 🇺🇸 Portland, Oregon, United States

AAPRI Clinical Research Institute ( Site 0051); 🇺🇸 Lincoln, Rhode Island, United States

Scroll for more (81 remaining)