Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 419
- 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
- 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)
Clinica Medica Especializada en Neumologia ( Site 0502)
🇬🇹Guatemala, Guatemala
Konkuk University Medical Center ( Site 1504)
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1503)
🇰🇷Seoul, Korea, Republic of
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1203)
🇵🇱Krakow, Malopolskie, Poland
Moscow City Clinical Hospital Number 13 ( Site 1460)
🇷🇺Moscow, Moskva, Russian Federation
Centrum Medyczne Pratia Bydgoszcz ( Site 1206)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Centrum Medyczne Pratia Katowice ( Site 1205)
🇵🇱Katowice, Slaskie, Poland
Hospital Ramon y Cajal ( Site 1815)
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Maranon ( Site 1823)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Private Clinic ( Site 0505)
🇬🇹Guatemala, Guatemala
Wonju Severance Christian Hospital ( Site 1502)
🇰🇷Wonju-si, Kang-won-do, Korea, Republic of
Asan Medical Center ( Site 1505)
🇰🇷Songpagu, Seoul, Korea, Republic of
Hospital Clinico San Carlos ( Site 1822)
🇪🇸Madrid, Spain
Asociacion Civil por la Salud ( Site 0602)
🇵🇪Lima, Peru
NZOZ CENTRUM ALERGOLOGII ( Site 1207)
🇵🇱Lublin, Lubelskie, Poland
Medinova North London Dedicated Research Centre ( Site 2705)
🇬🇧Northwood, United Kingdom
Hospital Clinico Universitario de Santiago ( Site 1820)
🇪🇸Santiago de Compostela, La Coruna, Spain
Family Clinic ( Site 1465)
🇷🇺Yekaterinburg, Sverdlovskaya Oblast, Russian Federation
State health Agency Ulyanovsk regional clinical hospital ( Site 1415)
🇷🇺Ulyanovsk, Ul Yanovskaya Oblast, Russian Federation
MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2803)
🇺🇦Zaporizhzhia, Zaporizka Oblast, Ukraine
Medical Center of LLC Medical Clinic Blahomed ( Site 2815)
🇺🇦Kyiv, Ukraine
MeDiNova Yorkshire Dedicated Research Centre ( Site 2715)
🇬🇧Shipley, Bradford, United Kingdom
West Walk Surgery ( Site 2700)
🇬🇧Yate, Gloucestershire, United Kingdom
Centrum Medyczne Silmedic Sp z o o ( Site 1204)
🇵🇱Katowice, Slaskie, Poland
Gyncentrum Clinic Sp. z o.o. ( Site 1208)
🇵🇱Katowice, Slaskie, Poland
Medinova South London Research Centre ( Site 2706)
🇬🇧Orpington, Kent, United Kingdom
Zhytomyr Central City Hospital No. 1 ( Site 2807)
🇺🇦Zhytomyr, Zhytomyrska Oblast, Ukraine
Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2811)
🇺🇦Kherson, Khersonska Oblast, Ukraine
Pulmonary Associates, PA ( Site 0016)
🇺🇸Phoenix, Arizona, United States
Springfield Clinic, LLP ( Site 0018)
🇺🇸Springfield, Illinois, United States
Center for Clinical Trials, LLC ( Site 0035)
🇺🇸Paramount, California, 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
Allergic Disease and Asthma Center ( Site 0027)
🇺🇸Greenville, South Carolina, United States
Diagnostics Research Group ( Site 0021)
🇺🇸San Antonio, Texas, United States
Allergy & Asthma Center ( Site 0001)
🇺🇸Waco, Texas, United States
Bellingham Asthma & Allergy ( Site 0011)
🇺🇸Bellingham, Washington, United States
Recherche GCP Research ( Site 0802)
🇨🇦Montreal, Quebec, Canada
Diex Recherche Quebec Inc ( Site 0805)
🇨🇦Quebec, Canada
Fundacion Centro de Investigacion Clinica CIC ( Site 0401)
🇨🇴Medellin, Antioquia, Colombia
Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)
🇨🇴Medellin, Antioquia, Colombia
Healthy Medical Center S.A.S ( Site 0404)
🇨🇴Zipaquira, Cundinamarca, Colombia
MedPlus Medicina Prepagada S.A. ( Site 0402)
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Centro Especializado en Enfermedades Pulmonares. ( Site 0410)
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Instituto Neumologico del Oriente ( Site 0403)
🇨🇴Floridablanca, Santander, Colombia
Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910)
🇩🇪Marburg, Hessen, Germany
Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0917)
🇩🇪Neu-Isenburg, Hessen, Germany
Pneumologicum im Suedstadtforum ( Site 0916)
🇩🇪Hannover, Niedersachsen, Germany
Pneumologisches Studienzentrum ( Site 0911)
🇩🇪Berlin, Germany
Celan SA ( Site 0500)
🇬🇹Guatemala, Guatemala
Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)
🇬🇹Guatemala, Guatemala
Odesa regional clinical hospital ( Site 2804)
🇺🇦Odesa, Odeska Oblast, Ukraine
City Polyclinic N20 ( Site 2806)
🇺🇦Odesa, Odeska Oblast, Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2814)
🇺🇦Vinnytsia, Vinnytska Oblast, Ukraine
Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)
🇺🇦Vinnytsya, Vinnytska Oblast, Ukraine
Volyn Regional Clinical Hospital ( Site 2816)
🇺🇦Lutsk, Volynska Oblast, Ukraine
Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800)
🇨🇦Quebec, Canada
Seoul National University Hospital ( Site 1501)
🇰🇷Seoul, Korea, Republic of
Clinica Belen ( Site 0604)
🇵🇪Piura, Peru
City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1401)
🇷🇺Kemerovo, Kemerovskaya Oblast, Russian Federation
Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1467)
🇷🇺Moscow, Moskva, Russian Federation
SPb SBHI City Consultative Diagnostic Center 1 ( Site 1409)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Clinica Ricardo Palma ( Site 0601)
🇵🇪San Isidro, Lima, Peru
Hospital Parc Tauli ( Site 1821)
🇪🇸Sabadell, Barcelona, Spain
Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200)
🇵🇱Zawadzkie, Opolskie, Poland
SEIHPE Saint Petersburg SMU ( Site 1435)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Limited Liability Company Kurator ( Site 1425)
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2802)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)
🇬🇹Guatemala, Guatemala
Instituto De Alergias y Enfermedades Respiratorias ( Site 0501)
🇬🇹Guatemala, Guatemala
Hospital Nacional Arzobispo Loayza ( Site 0607)
🇵🇪Lima, Peru
RCMed ( Site 1202)
🇵🇱Sochaczew, Mazowieckie, Poland
Centrum Medyczne Puławska ( Site 1215)
🇵🇱Warsaw, Mazowieckie, Poland
RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1417)
🇷🇺Belgorod, Belgorodskaya Oblast, Russian Federation
GBUZ Regional Clinical Hospital 3 ( Site 1421)
🇷🇺Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Voronezh Regional Clinical Hospital #1 ( Site 1441)
🇷🇺Voronezh, Voronezskaja Oblast, Russian Federation
SBCIH of the Yaroslavl region Central city hospital ( Site 1429)
🇷🇺Yaroslavl, Yaroslavskaya Oblast, Russian Federation
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1439)
🇷🇺Omsk, Omskaya Oblast, Russian Federation
GBUZ LO Center of Occupational Pathology ( Site 1447)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
advisory diagnostic center No.85 ( Site 1455)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1453)
🇷🇺Saratov, Saratovskaya Oblast, Russian Federation
Poltava City Clinical Hospital -1 ( Site 2813)
🇺🇦Poltava, Poltavska Oblast, Ukraine
Tidewater Physician Multispecialty Group, PC ( Site 0048)
🇺🇸Williamsburg, Virginia, United States