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Chronic CoughPhase 3NCT04193202

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

A Phase 3 study testing Gefapixant in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 91 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Cough
What is being tested?
Gefapixant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
419 participants
Where
91 sitesin 12 countries
Study dates
21 May 2020to 3 Nov 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

91 sites in 12 countries.

91 sites in 12 countries

Russia16 sites

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

    Belgorod, Belgorod Oblast, 308007

  • GBUZ Regional Clinical Hospital 3 ( Site 1421)

    Chelyabinsk, Chelyabinsk Oblast, 454021

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

    Kemerovo, Kemerovo Oblast, 650000

  • Moscow City Clinical Hospital Number 13 ( Site 1460)

    Moscow, Moscow, 115280

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

    Moscow, Moscow, 115419

  • Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1439)

    Omsk, Omsk Oblast, 644050

  • SPb SBHI City Consultative Diagnostic Center 1 ( Site 1409)

    Saint Petersburg, Sankt-Peterburg, 194354

  • GBUZ LO Center of Occupational Pathology ( Site 1447)

    Saint Petersburg, Sankt-Peterburg, 195271

  • Limited Liability Company Kurator ( Site 1425)

    Saint Petersburg, Sankt-Peterburg, 196240

  • SEIHPE Saint Petersburg SMU ( Site 1435)

    Saint Petersburg, Sankt-Peterburg, 197022

  • advisory diagnostic center No.85 ( Site 1455)

    Saint Petersburg, Sankt-Peterburg, 198260

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

    Saratov, Saratov Oblast, 410012

  • State health Agency Ulyanovsk regional clinical hospital ( Site 1415)

    Ulyanovsk, Ulyanovsk Oblast, 432063

  • Voronezh Regional Clinical Hospital #1 ( Site 1441)

    Voronezh, Voronezskaja Oblast, 394066

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

    Yaroslavl, Yaroslavl Oblast, 150040

  • Family Clinic ( Site 1465)

    Yekaterinburg, Sverdlovsk Oblast, 620109

Other trials in Russia

United States15 sites

  • Albuquerque Clinical Trials ( Site 0030)

    Albuquerque, New Mexico, 87102

  • Bellingham Asthma & Allergy ( Site 0011)

    Bellingham, Washington, 98225

  • American Health Research ( Site 0047)

    Charlotte, North Carolina, 28277

  • Allergic Disease and Asthma Center ( Site 0027)

    Greenville, South Carolina, 29607

  • AAPRI Clinical Research Institute ( Site 0051)

    Lincoln, Rhode Island, 02865

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

    Medford, Oregon, 97504

  • Center for Clinical Trials, LLC ( Site 0035)

    Paramount, California, 90723

  • Pulmonary Associates, PA ( Site 0016)

    Phoenix, Arizona, 85032

  • Northwest Research Center ( Site 0039)

    Portland, Oregon, 97202

  • Diagnostics Research Group ( Site 0021)

    San Antonio, Texas, 78229

  • Springfield Clinic, LLP ( Site 0018)

    Springfield, Illinois, 62703

  • Montefiore Einstein Center ( Site 0022)

    The Bronx, New York, 10461

  • Allergy & Asthma Center ( Site 0001)

    Waco, Texas, 76712

  • Chesapeake Clinical Research, Inc ( Site 0037)

    White Marsh, Maryland, 21162

  • Tidewater Physician Multispecialty Group, PC ( Site 0048)

    Williamsburg, Virginia, 23188

Other trials in United States

Ukraine14 sites

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

    Kherson, Kherson Oblast, 73000

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

    Kyiv, Kyivska Oblast, 03038

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

    Kyiv, Kyivska Oblast, 03038

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

    Kyiv, Kyivska Oblast, 03049

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

    Kyiv, Kyivska Oblast, 03057

  • Medical Center of LLC Medical Clinic Blahomed ( Site 2815)

    Kyiv, 01023

  • Volyn Regional Clinical Hospital ( Site 2816)

    Lutsk, Volyn Oblast, 43005

  • Odesa regional clinical hospital ( Site 2804)

    Odesa, Odesa Oblast, 65025

  • City Polyclinic N20 ( Site 2806)

    Odesa, Odesa Oblast, 65114

  • Poltava City Clinical Hospital -1 ( Site 2813)

    Poltava, Poltava Oblast, 36039

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

    Vinnytsia, Vinnytsia Oblast, 21001

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

    Vinnytsia, Vinnytsia Oblast, 21018

  • MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2803)

    Zaporizhzhya, Zaporizhzhia Oblast, 69096

  • Zhytomyr Central City Hospital No. 1 ( Site 2807)

    Zhytomyr, Zhytomyr Oblast, 10002

Other trials in Ukraine

Poland9 sites

  • Centrum Medyczne Pratia Bydgoszcz ( Site 1206)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Centrum Medyczne Pratia Katowice ( Site 1205)

    Katowice, Silesian Voivodeship, 40-081

  • Centrum Medyczne Silmedic Sp z o o ( Site 1204)

    Katowice, Silesian Voivodeship, 40-282

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

    Katowice, Silesian Voivodeship, 40-851

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

    Krakow, Lesser Poland Voivodeship, 30-033

  • NZOZ CENTRUM ALERGOLOGII ( Site 1207)

    Lublin, Lublin Voivodeship, 20-552

  • RCMed ( Site 1202)

    Sochaczew, Masovian Voivodeship, 96-500

  • Centrum Medyczne Puławska ( Site 1215)

    Warsaw, Masovian Voivodeship, 02-777

  • Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200)

    Zawadzkie, Opole Voivodeship, 47-120

Other trials in Poland

Colombia6 sites

  • MedPlus Medicina Prepagada S.A. ( Site 0402)

    Bogotá, Bogota D.C., 110221

  • Centro Especializado en Enfermedades Pulmonares. ( Site 0410)

    Bogotá, Bogota D.C., 111831

  • Instituto Neumologico del Oriente ( Site 0403)

    Floridablanca, Santander Department, 681004

  • Fundacion Centro de Investigacion Clinica CIC ( Site 0401)

    Medellín, Antioquia, 050021

  • Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)

    Medellín, Antioquia, 050036

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

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Guatemala6 sites

  • Celan SA ( Site 0500)

    Guatemala City, 01010

  • Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)

    Guatemala City, 01010

  • Clinica Medica Especializada en Neumologia ( Site 0502)

    Guatemala City, 01011

  • Private Clinic ( Site 0505)

    Guatemala City, 01011

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

    Guatemala City, 01015

  • Instituto De Alergias y Enfermedades Respiratorias ( Site 0501)

    Guatemala City, 01015

Other trials in Guatemala

South Korea5 sites

  • Seoul National University Hospital ( Site 1501)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 1503)

    Seoul, 03722

  • Konkuk University Medical Center ( Site 1504)

    Seoul, 05030

  • Asan Medical Center ( Site 1505)

    Songpagu, Seoul, 05505

  • Wonju Severance Christian Hospital ( Site 1502)

    Wŏnju, Kang-won-do, 26426

Other trials in South Korea

Spain5 sites

  • Hospital General Universitario Gregorio Maranon ( Site 1823)

    Madrid, Madrid, Comunidad de, 28007

  • Hospital Ramon y Cajal ( Site 1815)

    Madrid, 28034

  • Hospital Clinico San Carlos ( Site 1822)

    Madrid, 28040

  • Hospital Parc Tauli ( Site 1821)

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Santiago ( Site 1820)

    Santiago de Compostela, La Coruna, 15706

Other trials in Spain

Germany4 sites

  • Pneumologisches Studienzentrum ( Site 0911)

    Berlin, 10969

  • Pneumologicum im Suedstadtforum ( Site 0916)

    Hanover, Lower Saxony, 30173

  • Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910)

    Marburg, Hesse, 35037

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

    Neu-Isenburg, Hesse, 63263

Other trials in Germany

Peru4 sites

  • Asociacion Civil por la Salud ( Site 0602)

    Lima, 15046

  • Hospital Nacional Arzobispo Loayza ( Site 0607)

    Lima, 15082

  • Clinica Belen ( Site 0604)

    Piura, 20001

  • Clinica Ricardo Palma ( Site 0601)

    San Isidro, Lima region, 15036

Other trials in Peru

United Kingdom4 sites

  • Medinova North London Dedicated Research Centre ( Site 2705)

    Northwood, HA6 2RN

  • Medinova South London Research Centre ( Site 2706)

    Orpington, Kent, BR5 3QG

  • MeDiNova Yorkshire Dedicated Research Centre ( Site 2715)

    Shipley, Bradford, BD18 3SA

  • West Walk Surgery ( Site 2700)

    Yate, Gloucestershire, BS37 4AX

Other trials in United Kingdom

Canada3 sites

  • Recherche GCP Research ( Site 0802)

    Montreal, Quebec, H1M 1B1

  • Diex Recherche Quebec Inc ( Site 0805)

    Québec, Quebec, G1N 4V3

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

    Québec, Quebec, G1V 4W2

Other trials in Canada

About this study

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

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
Being tested
Gefapixant, Placebo
Keywords
Cough, Respiration disorders, Respiratory tract diseases, Signs and symptoms, respiratory, Signs and symptoms
Medical subject headings
Chronic Cough, Cough, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Signs and Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GefapixantDrug

    Also called MK-7264

    Administered twice daily as an oral tablet of 45 mg

  • PlaceboDrug

    Administered twice daily as a placebo oral tablet matching gefapixant

Study groups in NCT04193202
Study groupRoleWhat they receive
GefapixantExperimentalParticipants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Receives: Drug: Gefapixant
PlaceboPlacebo comparatorParticipants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 12

Secondary outcomes (3)

  1. Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at 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.

    Measured: Baseline, Week 12

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

    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.

    Measured: Up to approximately 14 weeks

  3. Percentage of Participants Who Discontinue Study Drug Due to an AE

    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.

    Measured: Up to approximately 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start21 May 2020
  3. Primary completion19 Oct 2021
  4. Study completion3 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193202
Sponsor's protocol ID
7264-043
Other IDs
MK-7264-043, 2019-002308-42, 2019
Status last verified
May 2023
First submitted
9 Dec 2019
Last updated
16 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 36879087

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gefapixant in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 91 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in Russia, United States, Ukraine, Poland, Colombia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04193202, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.

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