Clinical trial NCT04193202: Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
Official title: A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Cough
Keywords: Cough
Respiration disorders
Respiratory tract diseases
Signs and symptoms, respiratory
Signs and symptoms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With One or More Adverse Events (AEs)
timeFrame: Up to approximately 14 weeks
measure: Percentage of Participants Who Discontinue Study Drug Due to an AE
timeFrame: Up to approximately 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates, PA ( Site 0016)
state: Arizona
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC ( Site 0035)
state: California
city: Springfield
country: United States
facility: Springfield Clinic, LLP ( Site 0018)
state: Illinois
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc ( Site 0037)
state: Maryland
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials ( Site 0030)
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Einstein Center ( Site 0022)
state: New York
city: Charlotte
country: United States
facility: American Health Research ( Site 0047)
state: North Carolina
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC ( Site 0028)
state: Oregon
city: Portland
country: United States
facility: Northwest Research Center ( Site 0039)
state: Oregon
city: Lincoln
country: United States
facility: AAPRI Clinical Research Institute ( Site 0051)
state: Rhode Island
city: Greenville
country: United States
facility: Allergic Disease and Asthma Center ( Site 0027)
state: South Carolina
city: San Antonio
country: United States
facility: Diagnostics Research Group ( Site 0021)
state: Texas
city: Waco
country: United States
facility: Allergy & Asthma Center ( Site 0001)
state: Texas
city: Williamsburg
country: United States
facility: Tidewater Physician Multispecialty Group, PC ( Site 0048)
state: Virginia
city: Bellingham
country: United States
facility: Bellingham Asthma & Allergy ( Site 0011)
state: Washington
city: Montreal
country: Canada
facility: Recherche GCP Research ( Site 0802)
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc ( Site 0805)
city: Quebec
country: Canada
facility: Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800)
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0401)
state: Antioquia
city: Medellin
country: Colombia
facility: Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)
state: Antioquia
city: Zipaquira
country: Colombia
facility: Healthy Medical Center S.A.S ( Site 0404)
state: Cundinamarca
city: Bogota
country: Colombia
facility: MedPlus Medicina Prepagada S.A. ( Site 0402)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Centro Especializado en Enfermedades Pulmonares. ( Site 0410)
state: Distrito Capital De Bogota
city: Floridablanca
country: Colombia
facility: Instituto Neumologico del Oriente ( Site 0403)
state: Santander
city: Marburg
country: Germany
facility: Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910)
state: Hessen
city: Neu-Isenburg
country: Germany
facility: Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0917)
state: Hessen
city: Hannover
country: Germany
facility: Pneumologicum im Suedstadtforum ( Site 0916)
state: Niedersachsen
city: Berlin
country: Germany
facility: Pneumologisches Studienzentrum ( Site 0911)
city: Guatemala
country: Guatemala
facility: Celan SA ( Site 0500)
city: Guatemala
country: Guatemala
facility: Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)
city: Guatemala
country: Guatemala
facility: Clinica Medica Especializada en Neumologia ( Site 0502)
city: Guatemala
country: Guatemala
facility: Private Clinic ( Site 0505)
city: Guatemala
country: Guatemala
facility: Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)
city: Guatemala
country: Guatemala
facility: Instituto De Alergias y Enfermedades Respiratorias ( Site 0501)
city: Wonju-si
country: Korea, Republic of
facility: Wonju Severance Christian Hospital ( Site 1502)
state: Kang-won-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 1505)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1501)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 1503)
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center ( Site 1504)
city: San Isidro
country: Peru
facility: Clinica Ricardo Palma ( Site 0601)
state: Lima
city: Lima
country: Peru
facility: Asociacion Civil por la Salud ( Site 0602)
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza ( Site 0607)
city: Piura
country: Peru
facility: Clinica Belen ( Site 0604)
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz ( Site 1206)
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: NZOZ CENTRUM ALERGOLOGII ( Site 1207)
state: Lubelskie
city: Krakow
country: Poland
facility: Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1203)
state: Malopolskie
city: Sochaczew
country: Poland
facility: RCMed ( Site 1202)
state: Mazowieckie
city: Warsaw
country: Poland
facility: Centrum Medyczne Puławska ( Site 1215)
state: Mazowieckie
city: Zawadzkie
country: Poland
facility: Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200)
state: Opolskie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice ( Site 1205)
state: Slaskie
city: Katowice
country: Poland
facility: Centrum Medyczne Silmedic Sp z o o ( Site 1204)
state: Slaskie
city: Katowice
country: Poland
facility: Gyncentrum Clinic Sp. z o.o. ( Site 1208)
state: Slaskie
city: Belgorod
country: Russian Federation
facility: RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1417)
state: Belgorodskaya Oblast
city: Chelyabinsk
country: Russian Federation
facility: GBUZ Regional Clinical Hospital 3 ( Site 1421)
state: Chelyabinskaya Oblast
city: Kemerovo
country: Russian Federation
facility: City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1401)
state: Kemerovskaya Oblast
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital Number 13 ( Site 1460)
state: Moskva
city: Moscow
country: Russian Federation
facility: Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1467)
state: Moskva
city: Omsk
country: Russian Federation
facility: Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1439)
state: Omskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City Consultative Diagnostic Center 1 ( Site 1409)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: GBUZ LO Center of Occupational Pathology ( Site 1447)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SEIHPE Saint Petersburg SMU ( Site 1435)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: advisory diagnostic center No.85 ( Site 1455)
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Limited Liability Company Kurator ( Site 1425)
state: Sankt-Peterburg
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1453)
state: Saratovskaya Oblast
city: Yekaterinburg
country: Russian Federation
facility: Family Clinic ( Site 1465)
state: Sverdlovskaya Oblast
city: Ulyanovsk
country: Russian Federation
facility: State health Agency Ulyanovsk regional clinical hospital ( Site 1415)
state: Ul Yanovskaya Oblast
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital #1 ( Site 1441)
state: Voronezskaja Oblast
city: Yaroslavl
country: Russian Federation
facility: SBCIH of the Yaroslavl region Central city hospital ( Site 1429)
state: Yaroslavskaya Oblast
city: Sabadell
country: Spain
facility: Hospital Parc Tauli ( Site 1821)
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago ( Site 1820)
state: La Coruna
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 1823)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal ( Site 1815)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 1822)
city: Kherson
country: Ukraine
facility: Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2811)
state: Khersonska Oblast
city: Kyiv
country: Ukraine
facility: F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2802)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)
state: Kyivska Oblast
city: Odesa
country: Ukraine
facility: Odesa regional clinical hospital ( Site 2804)
state: Odeska Oblast
city: Odesa
country: Ukraine
facility: City Polyclinic N20 ( Site 2806)
state: Odeska Oblast
city: Poltava
country: Ukraine
facility: Poltava City Clinical Hospital -1 ( Site 2813)
state: Poltavska Oblast
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2814)
state: Vinnytska Oblast
city: Vinnytsya
country: Ukraine
facility: Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)
state: Vinnytska Oblast
city: Lutsk
country: Ukraine
facility: Volyn Regional Clinical Hospital ( Site 2816)
state: Volynska Oblast
city: Zaporizhzhia
country: Ukraine
facility: MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2803)
state: Zaporizka Oblast
city: Zhytomyr
country: Ukraine
facility: Zhytomyr Central City Hospital No. 1 ( Site 2807)
state: Zhytomyrska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Clinic Blahomed ( Site 2815)
city: Shipley
country: United Kingdom
facility: MeDiNova Yorkshire Dedicated Research Centre ( Site 2715)
state: Bradford
city: Yate
country: United Kingdom
facility: West Walk Surgery ( Site 2700)
state: Gloucestershire
city: Orpington
country: United Kingdom
facility: Medinova South London Research Centre ( Site 2706)
state: Kent
city: Northwood
country: United Kingdom
facility: Medinova North London Dedicated Research Centre ( Site 2705)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.