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

NCT04193202 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 7264-043MK-7264-0432019-002308-42
• Study Type: interventional
• Target: 419
• Locations: 12 countries
• Sites: 91

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.

Conditions

Chronic Cough

Keywords

Cough; Respiration disorders; Respiratory tract diseases; Signs and symptoms, respiratory; Signs and symptoms

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at 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.

  Baseline, Week 12

Secondary Outcomes (3)

• Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12

  Baseline, Week 12

• Percentage of Participants With One or More Adverse Events (AEs)

  Up to approximately 14 weeks

• Percentage of Participants Who Discontinue Study Drug Due to an AE

  Up to approximately 12 weeks

Study Arms (2)

Gefapixant

EXPERIMENTAL

Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.

Drug: Gefapixant

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.

Drug: Placebo

Interventions

Gefapixant DRUG

Administered twice daily as an oral tablet of 45 mg

Also known as: MK-7264

Gefapixant

Placebo DRUG

Administered twice daily as a placebo oral tablet matching gefapixant

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (91)

Pulmonary Associates, PA ( Site 0016)

Phoenix, Arizona, 85032, United States

Location

Center for Clinical Trials, LLC ( Site 0035)

Paramount, California, 90723, United States

Location

Springfield Clinic, LLP ( Site 0018)

Springfield, Illinois, 62703, United States

Location

Chesapeake Clinical Research, Inc ( Site 0037)

White Marsh, Maryland, 21162, United States

Location

Albuquerque Clinical Trials ( Site 0030)

Albuquerque, New Mexico, 87102, United States

Location

Montefiore Einstein Center ( Site 0022)

The Bronx, New York, 10461, United States

Location

American Health Research ( Site 0047)

Charlotte, North Carolina, 28277, United States

Location

Clinical Research Institute of Southern Oregon, PC ( Site 0028)

Medford, Oregon, 97504, United States

Location

Northwest Research Center ( Site 0039)

Portland, Oregon, 97202, United States

Location

AAPRI Clinical Research Institute ( Site 0051)

Lincoln, Rhode Island, 02865, United States

Location

Allergic Disease and Asthma Center ( Site 0027)

Greenville, South Carolina, 29607, United States

Location

Diagnostics Research Group ( Site 0021)

San Antonio, Texas, 78229, United States

Location

Allergy & Asthma Center ( Site 0001)

Waco, Texas, 76712, United States

Location

Tidewater Physician Multispecialty Group, PC ( Site 0048)

Williamsburg, Virginia, 23188, United States

Location

Bellingham Asthma & Allergy ( Site 0011)

Bellingham, Washington, 98225, United States

Location

Recherche GCP Research ( Site 0802)

Montreal, Quebec, H1M 1B1, Canada

Location

Diex Recherche Quebec Inc ( Site 0805)

Québec, Quebec, G1N 4V3, Canada

Location

Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800)

Québec, Quebec, G1V 4W2, Canada

Location

Fundacion Centro de Investigacion Clinica CIC ( Site 0401)

Medellín, Antioquia, 050021, Colombia

Location

Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)

Medellín, Antioquia, 050036, Colombia

Location

MedPlus Medicina Prepagada S.A. ( Site 0402)

Bogotá, Bogota D.C., 110221, Colombia

Location

Centro Especializado en Enfermedades Pulmonares. ( Site 0410)

Bogotá, Bogota D.C., 111831, Colombia

Location

Healthy Medical Center S.A.S ( Site 0404)

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Instituto Neumologico del Oriente ( Site 0403)

Floridablanca, Santander Department, 681004, Colombia

Location

Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910)

Marburg, Hesse, 35037, Germany

Location

Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0917)

Neu-Isenburg, Hesse, 63263, Germany

Location

Pneumologicum im Suedstadtforum ( Site 0916)

Hanover, Lower Saxony, 30173, Germany

Location

Pneumologisches Studienzentrum ( Site 0911)

Berlin, 10969, Germany

Location

Celan SA ( Site 0500)

Guatemala City, 01010, Guatemala

Location

Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)

Guatemala City, 01010, Guatemala

Location

Clinica Medica Especializada en Neumologia ( Site 0502)

Guatemala City, 01011, Guatemala

Location

Private Clinic ( Site 0505)

Guatemala City, 01011, Guatemala

Location

Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)

Guatemala City, 01015, Guatemala

Location

Instituto De Alergias y Enfermedades Respiratorias ( Site 0501)

Guatemala City, 01015, Guatemala

Location

Clinica Ricardo Palma ( Site 0601)

San Isidro, Lima region, 15036, Peru

Location

Asociacion Civil por la Salud ( Site 0602)

Lima, 15046, Peru

Location

Hospital Nacional Arzobispo Loayza ( Site 0607)

Lima, 15082, Peru

Location

Clinica Belen ( Site 0604)

Piura, 20001, Peru

Location

Centrum Medyczne Pratia Bydgoszcz ( Site 1206)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1203)

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

NZOZ CENTRUM ALERGOLOGII ( Site 1207)

Lublin, Lublin Voivodeship, 20-552, Poland

Location

RCMed ( Site 1202)

Sochaczew, Masovian Voivodeship, 96-500, Poland

Location

Centrum Medyczne Puławska ( Site 1215)

Warsaw, Masovian Voivodeship, 02-777, Poland

Location

Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200)

Zawadzkie, Opole Voivodeship, 47-120, Poland

Location

Centrum Medyczne Pratia Katowice ( Site 1205)

Katowice, Silesian Voivodeship, 40-081, Poland

Location

Centrum Medyczne Silmedic Sp z o o ( Site 1204)

Katowice, Silesian Voivodeship, 40-282, Poland

Location

Gyncentrum Clinic Sp. z o.o. ( Site 1208)

Katowice, Silesian Voivodeship, 40-851, Poland

Location

RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1417)

Belgorod, Belgorod Oblast, 308007, Russia

Location

GBUZ Regional Clinical Hospital 3 ( Site 1421)

Chelyabinsk, Chelyabinsk Oblast, 454021, Russia

Location

City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1401)

Kemerovo, Kemerovo Oblast, 650000, Russia

Location

Moscow City Clinical Hospital Number 13 ( Site 1460)

Moscow, Moscow, 115280, Russia

Location

Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1467)

Moscow, Moscow, 115419, Russia

Location

Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1439)

Omsk, Omsk Oblast, 644050, Russia

Location

SPb SBHI City Consultative Diagnostic Center 1 ( Site 1409)

Saint Petersburg, Sankt-Peterburg, 194354, Russia

Location

GBUZ LO Center of Occupational Pathology ( Site 1447)

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

Limited Liability Company Kurator ( Site 1425)

Saint Petersburg, Sankt-Peterburg, 196240, Russia

Location

SEIHPE Saint Petersburg SMU ( Site 1435)

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

advisory diagnostic center No.85 ( Site 1455)

Saint Petersburg, Sankt-Peterburg, 198260, Russia

Location

Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1453)

Saratov, Saratov Oblast, 410012, Russia

Location

Family Clinic ( Site 1465)

Yekaterinburg, Sverdlovsk Oblast, 620109, Russia

Location

State health Agency Ulyanovsk regional clinical hospital ( Site 1415)

Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

Location

Voronezh Regional Clinical Hospital #1 ( Site 1441)

Voronezh, Voronezskaja Oblast, 394066, Russia

Location

SBCIH of the Yaroslavl region Central city hospital ( Site 1429)

Yaroslavl, Yaroslavl Oblast, 150040, Russia

Location

Wonju Severance Christian Hospital ( Site 1502)

Wŏnju, Kang-won-do, 26426, South Korea

Location

Asan Medical Center ( Site 1505)

Songpagu, Seoul, 05505, South Korea

Location

Seoul National University Hospital ( Site 1501)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 1503)

Seoul, 03722, South Korea

Location

Konkuk University Medical Center ( Site 1504)

Seoul, 05030, South Korea

Location

Hospital Parc Tauli ( Site 1821)

Sabadell, Barcelona, 08208, Spain

Location

Hospital Clinico Universitario de Santiago ( Site 1820)

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital General Universitario Gregorio Maranon ( Site 1823)

Madrid, Madrid, Comunidad de, 28007, Spain

Location

Hospital Ramon y Cajal ( Site 1815)

Madrid, 28034, Spain

Location

Hospital Clinico San Carlos ( Site 1822)

Madrid, 28040, Spain

Location

Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2811)

Kherson, Kherson Oblast, 73000, Ukraine

Location

F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2802)

Kyiv, Kyivska Oblast, 03038, Ukraine

Location

F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)

Kyiv, Kyivska Oblast, 03038, Ukraine

Location

SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)

Kyiv, Kyivska Oblast, 03049, Ukraine

Location

SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)

Kyiv, Kyivska Oblast, 03057, Ukraine

Location

Odesa regional clinical hospital ( Site 2804)

Odesa, Odesa Oblast, 65025, Ukraine

Location

City Polyclinic N20 ( Site 2806)

Odesa, Odesa Oblast, 65114, Ukraine

Location

Poltava City Clinical Hospital -1 ( Site 2813)

Poltava, Poltava Oblast, 36039, Ukraine

Location

Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)

Vinnytsia, Vinnytsia Oblast, 21001, Ukraine

Location

Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2814)

Vinnytsia, Vinnytsia Oblast, 21018, Ukraine

Location

Volyn Regional Clinical Hospital ( Site 2816)

Lutsk, Volyn Oblast, 43005, Ukraine

Location

MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2803)

Zaporizhzhia, Zaporizhzhia Oblast, 69096, Ukraine

Location

Zhytomyr Central City Hospital No. 1 ( Site 2807)

Zhytomyr, Zhytomyr Oblast, 10002, Ukraine

Location

Medical Center of LLC Medical Clinic Blahomed ( Site 2815)

Kyiv, 01023, Ukraine

Location

MeDiNova Yorkshire Dedicated Research Centre ( Site 2715)

Shipley, Bradford, BD18 3SA, United Kingdom

Location

West Walk Surgery ( Site 2700)

Yate, Gloucestershire, BS37 4AX, United Kingdom

Location

Medinova South London Research Centre ( Site 2706)

Orpington, Kent, BR5 3QG, United Kingdom

Location

Medinova North London Dedicated Research Centre ( Site 2705)

Northwood, HA6 2RN, United Kingdom

Location

Related Publications (1)

• McGarvey L, Sher M, Shvarts YG, Lu S, Wu WC, Xu P, Schelfhout J, La Rosa C, Nguyen AM, Reyfman PA, Afzal AS. The Efficacy and Safety of Gefapixant in a Phase 3b Trial of Patients with Recent-Onset Chronic Cough. Lung. 2023 Apr;201(2):111-118. doi: 10.1007/s00408-023-00606-w. Epub 2023 Mar 6.

  PMID: 36879087 RESULT

MeSH Terms

Conditions

Chronic Cough; Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Interventions

Gefapixant

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 10, 2019
• Study Start: May 21, 2020
• Primary Completion: October 19, 2021
• Study Completion: November 3, 2021
• Last Updated: May 16, 2023
• Results First Posted: October 14, 2022

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

PE (4); DE (4); US (15); CA (3); KR (5); PL (9); CO (6); RU (16); ES (5); UA (14); GB (4); GU (6)