AzTrials
AzTrials

Chronic CoughPhase 3NCT03449147

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

A Phase 3 study testing Gefapixant 15 mg BID and Gefapixant 45 mg BID in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 171 sites in 20 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 primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. 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 15 mg BID and Gefapixant 45 mg BID
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,317 participants
Where
171 sitesin 20 countries
Study dates
15 Mar 2018to 30 Oct 2020
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 computed tomography scan of the thorax (within 5 years 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 sub-investigator
  • Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
  • Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
  • Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Who cannot join

  • Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
  • Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
  • Has a history of chronic bronchitis
  • Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
  • Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 at Screening OR an eGFR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal function
  • Has a history of malignancy ≤5 years
Show all 12Show fewer
  • Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
  • Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
  • Has a known allergy/sensitivity or contraindication to gefapixant
  • Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
  • Has previously received gefapixant
  • Currently participating in or has participated in an interventional clinical study within 30 days of screening

Trial locations and contacts

171 sites in 20 countries.

171 sites in 20 countries

United States34 sites

  • Albuquerque Clinical Trials ( Site 0039)

    Albuquerque, New Mexico, 87102

  • Paul A. Shapero, MD ( Site 0104)

    Bangor, Maine, 04401

  • Bellingham Asthma & Allergy ( Site 0076)

    Bellingham, Washington, 98225

  • Bethesda Allergy Asthma and Research Center LLC ( Site 0019)

    Bethesda, Maryland, 20814

  • Lowcountry Lung & Critical Care, PA ( Site 0045)

    Charleston, South Carolina, 29406

  • The Lung Research Center ( Site 0072)

    Chesterfield, Missouri, 63017

  • Rush University Medical Center ( Site 0103)

    Chicago, Illinois, 60612

  • University of Missouri ENT & Allergy Center ( Site 0066)

    Columbia, Missouri, 65201

  • Remington-Davis, Inc. ( Site 0082)

    Columbus, Ohio, 43215

  • Minnesota Lung Center ( Site 0108)

    Edina, Minnesota, 55435

  • Healthcare Research Network LLC ( Site 0093)

    Flossmoor, Illinois, 60422

  • Abraham Research, PLLC ( Site 0107)

    Fort Mitchell, Kentucky, 41017

  • Allergic Disease and Asthma Center ( Site 0043)

    Greenville, South Carolina, 29607

  • Clinical Research Consortium ( Site 0050)

    Las Vegas, Nevada, 89109

  • Clinical Research Institute of Southern Oregon, PC ( Site 0099)

    Medford, Oregon, 97504

  • Atlantic Research Center LLC ( Site 0012)

    Ocean City, New Jersey, 07712

  • CHI Health Creighton University Medical Center ( Site 0024)

    Omaha, Nebraska, 68134

  • Phoenix Medical Group ( Site 0022)

    Peoria, Arizona, 85381

  • Pulmonary Associates, PA ( Site 0063)

    Phoenix, Arizona, 85006

  • Allergy Associates Research Center ( Site 0026)

    Portland, Oregon, 97202

  • Wake Research Associates, LLC ( Site 0058)

    Raleigh, North Carolina, 27612

  • Clinical Research Partners, LLC. ( Site 0080)

    Richmond, Virginia, 23235

  • Mayo Clinic - Rochester ( Site 0006)

    Rochester, Minnesota, 55905

  • Clinical Research of Rock Hill ( Site 0079)

    Rock Hill, South Carolina, 29732

  • Allergy & Asthma Associates of SCV Research Center ( Site 0064)

    San Jose, California, 95117

  • Marycliff Clinical Research ( Site 0062)

    Spokane, Washington, 99202

  • Atlanta Allergy & Asthma Clinic PA ( Site 0029)

    Stockbridge, Georgia, 30281

  • Lenus Research & Medical Group Llc ( Site 0075)

    Sweetwater, Florida, 33172

  • Multicare Health System ( Site 0018)

    Tacoma, Washington, 98405

  • Clinical Research Consortium ( Site 0088)

    Tempe, Arizona, 85283

  • Montefiore Medical Center ( Site 0098)

    The Bronx, New York, 10461

  • AAPRI Clinical Research Institute ( Site 0001)

    Warwick, Rhode Island, 02886

  • Minnesota Lung Center ( Site 0041)

    Woodbury, Minnesota, 55125

  • Respiratory Medicine Research Institute of Michigan, PLC ( Site 0034)

    Ypsilanti, Michigan, 48197

Other trials in United States

United Kingdom18 sites

  • Belfast City Hospital ( Site 2705)

    Belfast, BT9 7AB

  • Synexus Midlands Clinical Research Centre Ltd ( Site 2719)

    Birmingham, Edgbaston, B15 2SQ

  • Medinova Lakeside Dedicated Research Centre ( Site 2710)

    Corby, Northamptonshire, NN17 2UR

  • Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 2704)

    Cottingham, East Yorkshire, HU16 5JQ

  • Synexus Scotland Clinical Research Centre ( Site 2721)

    Glasgow, G20 0SP

  • Medinova Warwickshire Dedicated Research Centre ( Site 2717)

    Kenilworth, Warwickshire, CV8 1JD

  • Synexus Merseyside Clinical Research Centre ( Site 2720)

    Liverpool, L22 OLG

  • Prince Phillip Hospital ( Site 2722)

    Llanelli, SA14 8QF

  • 1Kings College Hospital ( Site 2702)

    London, SE5 9RS

  • Synexus Manchester Clinical Research Centre ( Site 2718)

    Manchester, M15 6SE

  • Wythenshawe Hospital ( Site 2700)

    Manchester, M23 9LT

  • North Tyneside General Hospital ( Site 2707)

    North Shields, NE29 8NH

  • Medinova North London Dedicated Research Centre ( Site 2716)

    Northwood, Middlesex, HA6 2RN

  • Medinova East London Dedicated Research Centre ( Site 2715)

    Romford, Essex, RM1 3PJ

  • Rothwell Medical Centre ( Site 2712)

    Rothwell, NN14 6JQ

  • Medinova South London Dedicated Research Centre ( Site 2714)

    Sidcup, Kent, DA14 6LT

  • Taunton and Somerset Hospital ( Site 2723)

    Taunton, TA1 5DA

  • West Walk Surgery ( Site 2711)

    Yate, BS37 4AX

Other trials in United Kingdom

Ukraine15 sites

  • Chernihiv City hospital N2 ( Site 2801)

    Chernihiv, 14034

  • CE Chernivtsi state city clinical hospital 3 ( Site 2806)

    Chernivtsi, 58022

  • Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2812)

    Kherson, 73000

  • Medical Clinic Blagomed LLC ( Site 2807)

    Kiev, 01023

  • Kyiv City Tuberculosis Hospital No. 1 ( Site 2814)

    Kyiv, 02091

  • Medical Association Medbud of the PJSC Kyivmiskbud ( Site 2803)

    Kyiv, 03037

  • SE Road Clinical Hospital 2 of Kyiv station ( Site 2809)

    Kyiv, 03049

  • Institute of Otolaryngology n. a. Prof. A. I. Kolomiychenko ( Site 2833)

    Kyiv, 03067

  • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2804)

    Kyiv, 03680

  • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)

    Kyiv, 03680

  • Volyn Regional Clinical Hospital ( Site 2829)

    Lutsk, 43005

  • Poltava City Clinical Hospital 1 ( Site 2808)

    Poltava, 36039

  • Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2819)

    Vinnytsia, 21018

  • MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2811)

    Zaporizhzhya, 69065

  • Zhytomyr Central City Hospital #1 ( Site 2828)

    Zhytomyr, 10002

Other trials in Ukraine

Poland14 sites

  • Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)

    Bialystok, 15-044

  • KLIMED ( Site 1902)

    Bychawa, 23-100

  • Centrum Medyczne Pratia Katowice ( Site 1917)

    Katowice, Silesian Voivodeship, 40-081

  • Centrum Medyczne Silmedic Sp z o o ( Site 1920)

    Katowice, Silesian Voivodeship, 40-282

  • Gyncentrum Clinic Sp. z o.o. ( Site 1908)

    Katowice, 40-851

  • Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)

    Krakow, 30-033

  • Centrum Nowoczesnych Terapii Dobry Lekarz ( Site 1924)

    Krakow, 31-011

  • Uniwersytecki Szpital Kliniczny im. Norberta Barlickiego nr 1 ( Site 1921)

    Lodz, 90-141

  • NZOZ CENTRUM ALERGOLOGII ( Site 1909)

    Lublin, Lublin Voivodeship, 20-552

  • Ostrowieckie Centrum Medyczne ( Site 1915)

    Ostrowiec Świętokrzyski, 27-400

  • RCMed ( Site 1912)

    Sochaczew, 96-500

  • Lubelskie Centrum Diagnostyczne ( Site 1913)

    Świdnik, 21-040

  • Centrum Medyczne Pratia Warszawa ( Site 1911)

    Warsaw, 01-868

  • Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1923)

    Zawadzkie, 47-120

Other trials in Poland

Colombia10 sites

  • Neumo Investigaciones SAS ( Site 0622)

    Bogota, Cundinamarca, 110311

  • Centro Especializado en Enfermedades Pulmonares. ( Site 0620)

    Bogota, Cundinamarca, 111831

  • MedPlus Medicina Prepagada S.A. ( Site 0612)

    Bogotá, 110221

  • Instituto Neumologico del Oriente S.A. ( Site 0649)

    Bucaramanga, 681004

  • Fundacion Valle del Lili ( Site 0618)

    Cali, Valle del Cauca Department, 760032

  • Centro Medico Imbanaco de Cali S.A ( Site 0619)

    Cali, Valle del Cauca Department, 760042

  • Fundacion Centro de Investigacion Clinica CIC ( Site 0603)

    Medellín, Antioquia, 050021

  • Hospital Pablo Tobon Uribe ( Site 0600)

    Medellín, Antioquia, 050034

  • Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0602)

    Medellín, Antioquia, 050036

  • Inst. Prestadora de Servicios de Salud Universidad Antioquia ( Site 0621)

    Medellín, 050010

Other trials in Colombia

Turkey (Türkiye)9 sites

  • Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2612)

    Adana, 01330

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2602)

    Ankara, 06100

  • Uludag Universitesi Tip Fakultesi ( Site 2621)

    Bursa, Gorukle, 16059

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi ( Site 2619)

    Edirne, 22030

  • Istanbul Universitesi Istanbul Tip Fakultesi Gogus Hastalıklari ABD ( Site 2610)

    Istanbul, 34093

  • SSK Sureyyapasa Gogus Hastaliklari Hastanesi ( Site 2608)

    Istanbul, 34844

  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2603)

    Izmir, 35040

  • SBU Dr. Suat Seren Gogus Hast. ve Cer. Egitim ve Arastirma Hast. ( Site 2604)

    Izmir, 35110

  • Celal Bayar University Faculty of Medicine ( Site 2614)

    Manisa, 45030

Other trials in Turkey (Türkiye)

Canada8 sites

  • Hamilton Medical Research Group ( Site 0510)

    Hamilton, Ontario, L8M 1K7

  • Recherche GCP Research ( Site 0500)

    Montreal, Quebec, H1M 1B1

  • Diex Recherche Quebec Inc ( Site 0515)

    Québec, Quebec, G1N 4V3

  • Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0504)

    Québec, Quebec, G1V 4W2

  • Clinique de Pneumologie et du Sommeil de Lanaudiere- CPSL ( Site 0516)

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Q & T Research Sherbrooke Inc. ( Site 0512)

    Sherbrooke, Quebec, J1J 2G2

  • CIC Mauricie Inc. ( Site 0503)

    Trois-Rivières, Quebec, G8T 7A1

  • Diex Recherche Victoriaville Inc. ( Site 0514)

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

China8 sites

  • Peking University Third Hospital ( Site 5005)

    Beijing, 100191

  • The First Affiliated Hospital of Fujian Medical University ( Site 5017)

    Fuzhou, Fujian, 350005

  • The First Affiliated Hospital of Guangzhou Medical University ( Site 5000)

    Guangzhou, Guangdong, 510120

  • The First Affiliated Hospital of Zhejiang University ( Site 5014)

    Hangzhou, Zhejiang, 310003

  • Inner Mongolia Autonomous Region Hospital ( Site 5018)

    Hohhot, Inner Mongolia, 010017

  • The First Affiliated Hospital of Nanchang University ( Site 5012)

    Nanchang, Jiangxi, 330006

  • Shanghai General Hospital ( Site 5010)

    Shanghai, Shanghai Municipality, 200080

  • ShengJing Hospital of China Medical University ( Site 5024)

    Shenyang, Liaoning, 110004

Other trials in China

Hungary8 sites

  • Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)

    Balassagyarmat, 2660

  • Synexus Magyarorszag Kft. ( Site 1208)

    Budapest, 1036

  • Erzsebet Gondozohaz ( Site 1207)

    Gödöllő, 2100

  • Synexus Magyarorszag Kft. ( Site 1210)

    Gyula, 5700

  • Lumniczer Sandor Korhaz es Rendelointezet ( Site 1212)

    Kapuvár, 9330

  • CRU Hungary KFT ( Site 1205)

    Miskolc, 3529

  • Da Vinci Private Clinic - Da Vinci Maganklinika ( Site 1201)

    Pécs, 7626

  • Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft ( Site 1203)

    Püspökladány, 4150

Other trials in Hungary

Germany7 sites

  • Aerztezentrum Axel Springer Passage ( Site 1009)

    Berlin, 10969

  • Atemwegszentrum Neukoeln ( Site 1003)

    Berlin, 12043

  • Gemeinschaftspraxis Zentrum ( Site 1005)

    Frankfurt, 60318

  • Pneumologicum im Suedstadtforum ( Site 1004)

    Hanover, 30173

  • Pneumologenzentrum ( Site 1006)

    Leipzig, 04207

  • Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 1011)

    Neu-Isenburg, 63263

  • PneumoConsult Ulm ( Site 1008)

    Ulm, 89073

Other trials in Germany

South Africa7 sites

  • Iatros International ( Site 2130)

    Brandwag, Bloemfontein, 9301

  • UCT Lung Institute - Bateman ( Site 2126)

    Cape Town, Western Cape, 7700

  • I Engelbrecht Research ( Site 2128)

    Centurion, Tswane, 0157

  • Rochester Place Medical Centre ( Site 2129)

    Morningside, Gauteng, 2196

  • Jongaie Research ( Site 2131)

    Pretoria, Gauteng, 0183

  • Dr N K Gounden Mediclinic ( Site 2134)

    Shallcross, KwaZulu-Natal, 4093

  • Drs Lalloo & Ambaram ( Site 2132)

    Umhlanga Ridge, KwaZulu-Natal, 4319

Other trials in South Africa

Malaysia6 sites

  • Hospital Sultanah Bahiyah ( Site 1607)

    Alor Star, Kedah, 05460

  • Universiti Teknologi MARA ( Site 1602)

    Batu Caves, Selangor, 68100

  • Hospital Pulau Pinang. ( Site 1606)

    George Town, Pulau Pinang, 10990

  • Institut Perubatan Respiratori ( Site 1605)

    Kuala Lumpur, 53000

  • University Malaya Medical Centre ( Site 1601)

    Kuala Lumpur, 59100

  • Hospital Taiping ( Site 1600)

    Taiping, Perak, 34000

Other trials in Malaysia

Czechia5 sites

  • MUDr. I. Cierna Peterova s.r.o. ( Site 0707)

    Brandýs nad Labem, 250 01

  • MediTrial s.r.o ( Site 0702)

    Jindrichuv Hradec III, 377 01

  • Ordinace Pneumologie a diagnostiky Plicnich funkci ( Site 0705)

    Karlovy Vary, 360 17

  • PNEUMO-NB s.r.o. ( Site 0710)

    Nový Bor, 473 01

  • Nemocnice Tabor a.s. ( Site 0703)

    Tábor, 390 03

Other trials in Czechia

Guatemala5 sites

  • Clinipharm ( Site 2902)

    Guatemala City, 01001

  • Celan SA ( Site 2900)

    Guatemala City, 01010

  • Consultorio Privado Dr. Jeremias Guerra ( Site 2909)

    Guatemala City, 01010

  • Clinica Medica Especializada en Neumologia ( Site 2901)

    Guatemala City, 01011

  • Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2903)

    Guatemala City, 01015

Other trials in Guatemala

Peru5 sites

  • Hospital Nacional Adolfo Guevara Velasco ( Site 1808)

    Cusco, 08000

  • Clinica Internacional ( Site 1801)

    Lima, 15001

  • Asociacion Civil por la Salud ( Site 1805)

    Lima, 15046

  • Hospital Nacional Cayetano Heredia [Lima, Peru] ( Site 1806)

    Lima, 15102

  • Clinica Ricardo Palma ( Site 1802)

    San Isidro, Lima region, 15036

Other trials in Peru

Australia4 sites

  • Royal Adelaide Hospital [Adelaide, Australia] ( Site 0214)

    Adelaide, South Australia, 5000

  • Australian Clinical Research Network ( Site 0201)

    Maroubra, New South Wales, 2035

  • Trialswest ( Site 0208)

    Murdoch, 6150

  • Holdsworth House Medical Practice ( Site 0206)

    Sydney, New South Wales, 2010

Other trials in Australia

New Zealand4 sites

  • Southern Clinical Trials - Waitemata ( Site 0230)

    Auckland, 0626

  • Middlemore Clinical Trials ( Site 0232)

    Auckland, 2025

  • Lakeland Clinical Trials ( Site 0233)

    Rotorua, 3010

  • P3 Research Ltd. ( Site 0228)

    Tauranga, 3110

Other trials in New Zealand

Denmark2 sites

  • Herlev Hospital ( Site 0803)

    Herlev, 2730

  • Bispebjerg Hospital ( Site 0804)

    København NV, 2400

Other trials in Denmark

Israel1 site

  • Kaplan Medical Center ( Site 1300)

    Rehovot, 7661041

Other trials in Israel

Italy1 site

  • Azienda Ospedaliero Universitaria Careggi ( Site 1400)

    Florence, 50134

Other trials in Italy

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

Read the detailed description

This study will have a main 24-week treatment period and a 28-week extension period of treatment (total treatment period of 52 weeks). Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 12-week, Off-treatment Durability Study Period. Any assessments conducted in the observational period will be exploratory.

Conditions
Chronic Cough
Being tested
Placebo, Gefapixant 15 mg BID, Gefapixant 45 mg BID
Medical subject headings
Chronic Cough

What participants receive

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

  • PlaceboDrug

    Placebo tablet administered orally BID

  • Gefapixant 15 mg BIDDrug

    Also called MK-7264

    Gefapixant 15 mg tablet administered orally BID

  • Gefapixant 45 mg BIDDrug

    Also called MK-7264

    Gefapixant 45 mg tablet administered orally BID

Study groups in NCT03449147
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive a matching placebo tablet BID during the 24-week main study period and the 28-week extension period.
Receives: Drug: Placebo
Gefapixant 15 mg BIDExperimentalParticipants will receive a gefapixant 15 mg tablet BID and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and the 28-week extension period.
Receives: Drug: Placebo; Drug: Gefapixant 15 mg BID
Gefapixant 45 mg BIDExperimentalParticipants will receive a gefapixant 45 mg tablet BID and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and during the 28-week extension period.
Receives: Drug: Placebo; Drug: Gefapixant 45 mg BID

What is being measured

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

  1. Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline

    24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.

    Measured: Baseline, Week 24

  2. Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up

    An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to 54 Weeks

  3. Number of Participants Who Discontinued a Study Drug Due to an AE

    An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to 52 weeks

Secondary outcomes (6)

  1. Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline

    Awake coughs per hour was defined as the average hourly cough frequency while the participant is awake, based on a 24-hour interval of sound recordings using a digital recording device (cough monitor). ANCOVA model was applied to log-transformed cough data to determine GM of awake coughs per hour at baseline and week 24. The GMR (Week 24 GM awake coughs per hour divided by Baseline GM awake coughs per hour) is reported.

    Measured: Baseline, Week 24

  2. Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24

    The 19-item LCQ assessed the impact of chronic cough in three health-related quality of life (HRQoL) domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at Week 24. The percentage of participants (logistic regression model-based) with a ≥1.3-point increase in the LCQ total score at Week 24 is presented.

    Measured: Baseline, Week 24

  3. Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24

    24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A clinically meaningful improvement from baseline is defined as a ≤-30% change (≥30% reduction) in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented.

    Measured: Baseline, Week 24

  4. Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24

    The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-1.3 point change from baseline in CSD at Week 24 (or ≥1.3 point reduction from baseline) is reported.

    Measured: Baseline, Week 24

  5. Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24

    The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-2.7 point change from baseline in CSD at Week 24 (or ≥2.7 point reduction from baseline) is reported.

    Measured: Baseline, Week 24

  6. Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24

    The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was defined as the average of the VAS scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-30 mm change from baseline in cough severity VAS score at Week 24 is reported.

    Measured: Baseline, Week 24

Timeline

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

  1. First posted28 Feb 2018
  2. Study start15 Mar 2018
  3. Primary completion20 Aug 2020
  4. Study completion30 Oct 2020

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
Model description
Participants with refractory or unexplained chronic cough will be randomized to 1 of 3 treatment groups: gefapixant 45 mg twice daily (BID), gefapixant 15 mg BID, or placebo.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03449147
Sponsor's protocol ID
7264-030
Other IDs
MK-7264-030, 2017-003559-49, 2017
Status last verified
Aug 2021
First submitted
22 Feb 2018
Last updated
2 Sep 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Dicpinigaitis PV, Birring SS, Blaiss M, McGarvey LP, Morice AH, Pavord ID, Satia I, Smith JA, La Rosa C, Li Q, Nguyen AM, Schelfhout J, Tzontcheva A, Muccino D. Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough. Ann Allergy Asthma Immunol. 2023 Jan;130(1):60-66. doi: 10.1016/j.anai.2022.05.003. Epub 2022 May 13.

    PubMed 35569802

  • McGarvey LP, Birring SS, Morice AH, Dicpinigaitis PV, Pavord ID, Schelfhout J, Nguyen AM, Li Q, Tzontcheva A, Iskold B, Green SA, Rosa C, Muccino DR, Smith JA; COUGH-1 and COUGH-2 Investigators. Efficacy and safety of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials. Lancet. 2022 Mar 5;399(10328):909-923. doi: 10.1016/S0140-6736(21)02348-5.

    PubMed 35248186

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gefapixant 15 mg BID and Gefapixant 45 mg BID in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 171 sites in 20 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, United Kingdom, Ukraine, Poland, Colombia and 15 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 2 Sep 2021). 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?

Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline (time frame: Baseline, Week 24). The study lists 3 primary outcomes in all. 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 NCT03449147, which also lists 2 linked publications.

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 2 Sep 2021.

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