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AzTrials

Chronic CoughPhase 3NCT03449134

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)

A Phase 3 study testing Gefapixant in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 156 sites in 17 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 main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
732 participants
Where
156 sitesin 17 countries
Study dates
14 Mar 2018to 17 Aug 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
  • Female participants are eligible if not pregnant, not breastfeeding, and either not of childbearing potential, or agree 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
  • Has forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <60%
  • 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) <30mL/min/1.73 m^2 at Screening OR eGFR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal function
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  • Has a history of malignancy <=5 years
  • 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 systolic blood pressure >160 mm Hg or diastolic blood pressure >90 mm Hg at Screening
  • 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 or is currently participating in or has participated in an interventional clinical study
  • Had significantly abnormal laboratory tests at Screening

Trial locations and contacts

156 sites in 17 countries.

156 sites in 17 countries

Japan38 sites

  • Fujisawa City Hospital ( Site 1505)

    Fujisawa, Kanagawa, 251-8550

  • National Hospital Organization Fukuoka Hospital ( Site 1552)

    Fukuoka, 811-1394

  • Osaka Habikino Medical Center ( Site 1546)

    Habikino, Osaka, 583-8588

  • Tokyo Medical University Hachioji Medical Center ( Site 1569)

    Hachiōji, Tokyo, 193-0998

  • Kawaguchi Respiratory Clinic ( Site 1504)

    Higashiosaka, Osaka, 577-0843

  • Terada Clinic Respiratory Medicine & General Practice ( Site 1565)

    Himeji, Hyōgo, 670-0849

  • Hiroshima Allergy & Respiratory Clinic ( Site 1529)

    Hiroshima, 732-0052

  • Kinki Central Hospital ( Site 1576)

    Itami, Hyōgo, 664-8533

  • Itami City Hospital ( Site 1580)

    Itami, Hyōgo, 664-8540

  • Ishikawa Prefectural Central Hospital ( Site 1554)

    Kanazawa, Ishikawa-ken, 920-8530

  • Kanazawa University Hospital ( Site 1536)

    Kanazawa, Ishikawa-ken, 920-8641

  • National Hospital Organization Tokyo National Hospital ( Site 1557)

    Kiyose, Tokyo, 204-8585

  • Komatsu Municipal Hospital ( Site 1508)

    Komatsu, Ishikawa-ken, 923-8560

  • Kyoto University Hospital ( Site 1547)

    Kyoto, 606-8507

  • Matsusaka City Hospital ( Site 1525)

    Matsusaka, Mie-ken, 515-8544

  • Nagaoka Red Cross Hospital ( Site 1507)

    Nagaoka, Niigata, 940-2085

  • National Hospital Organization Nagoya Medical Center ( Site 1539)

    Nagoya, Aichi-ken, 460-0001

  • Nagoya City University Hospital ( Site 1528)

    Nagoya, Aichi-ken, 467-8602

  • National Hospital Organization Ibarakihigashi National Hospital ( Site 1526)

    Naka-gun, Ibaraki, 319-1113

  • JA Niigatakoseiren Niigata Medical Center ( Site 1522)

    Niigata, 950-2022

  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 1519)

    Sakai, Osaka, 591-8555

  • Idaimae Minamiyojo Int Clinic ( Site 1521)

    Sapporo, Hokkaido, 064-0804

  • Shimonoseki City Hospital ( Site 1573)

    Shimonoseki, Yamaguchi, 750-8520

  • Shizuoka Prefectural Hospital Organization Shizuoka General Hospital ( Site 1524)

    Shizuoka, 420-8527

  • National Hospital Organization Disaster Medical Center ( Site 1558)

    Tachikawa, Tokyo, 190-0014

  • Kamei Internal Medicine and Respiratory Clinic ( Site 1509)

    Takamatsu, Kagawa-ken, 761-8073

  • Juntendo University Hospital ( Site 1578)

    Tokyo, 113-8431

  • Tokyo Shinagawa Hospital ( Site 1560)

    Tokyo, 140-8522

  • Showa University Hospital ( Site 1531)

    Tokyo, 142-8666

  • Center Hospital of the National Center for Global Health and Medicine ( Site 1574)

    Tokyo, 162-8655

  • Tokyo Metropolitan Geriatric Hospital ( Site 1577)

    Tokyo, 173-0015

  • National Hospital Organization Ehime Medical Center ( Site 1556)

    Tōon, Ehime, 791-0281

  • National Hospital Organization Minami-Okayama Medical Center ( Site 1553)

    Tsukubo-gun, Okayama-ken, 701-0304

  • Urasoe General Hospital ( Site 1572)

    Urasoe, Okinawa, 901-2132

  • Yokohama City Minato Red Cross Hospital ( Site 1506)

    Yokohama, Kanagawa, 231-8682

  • Medical Corporation Shintokai Yokohama Minoru Clinic ( Site 1568)

    Yokohama, Kanagawa, 232-0064

  • Saiseikai Yokohamashi Nanbu Hospital ( Site 1533)

    Yokohama, Kanagawa, 234-8503

  • Kanagawa Cardiovascular and Respiratory Center ( Site 1503)

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

United States27 sites

  • Sirius Clinical Research, LLC ( Site 0102)

    Austin, Texas, 78759

  • American Health Research ( Site 0082)

    Charlotte, North Carolina, 28207

  • Charlottesville Medical Research Center, LLC ( Site 0006)

    Charlottesville, Virginia, 22911

  • Bernstein Clinical Research Center, LLC ( Site 0005)

    Cincinnati, Ohio, 45231

  • Pharmaceutical Research & Consulting, Inc. ( Site 0029)

    Dallas, Texas, 75231

  • Mainland Medical Research Institute ( Site 0003)

    Dickinson, Texas, 77539

  • Intermountain Clinical Research ( Site 0033)

    Draper, Utah, 84020

  • Asthma Nasal Disease & Allergy Research Center of New England ( Site 0075)

    East Providence, Rhode Island, 02914

  • Clinical Research of Gastonia ( Site 0043)

    Gastonia, North Carolina, 28054

  • The Center for Pharmaceutical Research PC ( Site 0016)

    Kansas City, Missouri, 64114

  • Biosolutions Clinical Research Center ( Site 0070)

    La Mesa, California, 91942

  • Sher Allergy Specialists/Center For Cough ( Site 0078)

    Largo, Florida, 33778

  • Research Solutions of Arizona PC ( Site 0036)

    Litchfield Park, Arizona, 85340

  • Well Pharma Medical Research, Corp. ( Site 0093)

    Miami, Florida, 33143

  • Clinical Research Institute LLC ( Site 0004)

    Minneapolis, Minnesota, 55402

  • Midwest Allergy Sinus Asthma, SC ( Site 0081)

    Normal, Illinois, 61761

  • Center for Clinical Trials, LLC ( Site 0059)

    Paramount, California, 90723

  • Pulmonary Associates of Richmond Inc. ( Site 0101)

    Richmond, Virginia, 23225

  • National Clinical Research-Richmond, Inc. ( Site 0073)

    Richmond, Virginia, 23294

  • Diagnostics Research Group ( Site 0035)

    San Antonio, Texas, 78229

  • Medical Research of AZ ( Site 0060)

    Scottsdale, Arizona, 85251

  • BreatheAmerica Inc ( Site 0048)

    Shreveport, Louisiana, 71106

  • Cotton-O'Neil Clinical Research Center ( Site 0052)

    Topeka, Kansas, 66606

  • Vital Prospects Clinical Research Institute, PC ( Site 0037)

    Tulsa, Oklahoma, 74136

  • Allergy & Asthma Center ( Site 0001)

    Waco, Texas, 76712

  • Lung and Sleep Specialists ( Site 0091)

    Williamsburg, Virginia, 23188

  • Florida Pulmonary Research Institute, LLC ( Site 0019)

    Winter Park, Florida, 32789

Other trials in United States

South Korea12 sites

  • Hallym University Sacred Heart Hospital ( Site 2208)

    Anyang-si, Gyeonggi-do, 14068

  • Incheon St. Mary s Hospital ( Site 2200)

    Incheon, 21431

  • Seoul National University Hospital ( Site 2210)

    Seoul, 03080

  • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2209)

    Seoul, 03312

  • Severance Hospital ( Site 2204)

    Seoul, 03722

  • Konkuk University Medical Center ( Site 2205)

    Seoul, 05030

  • Asan Medical Center ( Site 2203)

    Seoul, 05505

  • Samsung Medical Center ( Site 2212)

    Seoul, 06351

  • The Catholic University of Korea St. Mary s Hospital ( Site 2215)

    Seoul, 06591

  • Korea University Guro Hospital ( Site 2213)

    Seoul, 08308

  • Ajou University Hospital ( Site 2211)

    Suwon, Gyeonggi-do, 16499

  • Wonju Severance Christian Hospital ( Site 2214)

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

United Kingdom10 sites

  • Belfast City Hospital ( Site 2705)

    Belfast, BT9 7AB

  • Broomfield Hospital ( Site 2722)

    Chelmsford, CM1 7ET

  • Medinova Lakeside Dedicated Research Centre ( Site 2710)

    Corby, Northamptonshire, NN17 2UR

  • Glenfield Hospital ( Site 2701)

    Leicester, LE3 9QP

  • Royal Brompton Hospital ( Site 2703)

    London, SW3 6JY

  • Wythenshawe Hospital ( Site 2700)

    Manchester, M23 9LT

  • Churchill Hospital ( Site 2706)

    Oxford, OX3 7LE

  • Royal Preston Hospital ( Site 2709)

    Preston, Lancashire, PR2 9HT

  • Rothwell Medical Centre ( Site 2712)

    Rothwell, NN14 6JQ

  • MeDiNova Yorkshire Dedicated Research Centre ( Site 2708)

    Shipley, BD18 3SA

Other trials in United Kingdom

Argentina9 sites

  • CEMEDIC - Centro de Especialidades Medicas ( Site 0304)

    Buenos Aires, C1407GTN

  • Centro Medico Dra De Salvo ( Site 0310)

    Buenos Aires, C1426ABP

  • InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)

    Caba, Buenos Aires, C1425BEN

  • Fundacion CIDEA ( Site 0323)

    Ciudad de Buenos Aires, Buenos Aires, C1121ABE

  • Hospital Privado Universitario de Cordoba ( Site 0313)

    Córdoba, X5016KEH

  • Instituto Ave Pulmo ( Site 0322)

    Mar del Plata, Buenos Aires, B7602DCK

  • Fundacion Scherbovsky ( Site 0300)

    Mendoza, M5500AXR

  • Centro Medico Privado de Reumatologia ( Site 0309)

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • Investigaciones en Patologias Respiratorias ( Site 0325)

    San Miguel de Tucumán, Tucumán Province, T4000IAR

Other trials in Argentina

Poland9 sites

  • Prywatny Gabinet Internistyczno ( Site 1928)

    Bialystok, 15-010

  • Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)

    Bialystok, 15-044

  • Centrum Medyczne Pratia Bydgoszcz ( Site 1418)

    Bydgoszcz, 85-796

  • Centrum Medyczne Pratia Czestochowa ( Site 1926)

    Częstochowa, 42-200

  • Centrum Medyczne Pratia Gdynia ( Site 1910)

    Gdynia, 81-338

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

    Krakow, 30-033

  • USK nr 1 ( Site 1921)

    Lodz, 90-153

  • Prywatny Gabinet Specjalistyczny ( Site 1927)

    Lodz, 91-849

  • NZOZCentrum Medyczne Kermed ( Site 1905)

    Żnin, 88-400

Other trials in Poland

Canada7 sites

  • Recherche GCP Research ( Site 0500)

    Montreal, Quebec, H1M 1B1

  • 167877 Canada Inc. Dr. Jaime Del Carpio ( Site 0506)

    Montreal, Quebec, H3G 1L5

  • Dynamik Research ( Site 0505)

    Pointe-Claire, Quebec, H9R 3J1

  • Diex Recherche Quebec Inc ( Site 0515)

    Québec, Quebec, G1N 4V3

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

    Sherbrooke, Quebec, J1J 2G2

  • Canadian Phase Onward Inc. ( Site 0509)

    Toronto, Ontario, M3J 2C5

  • CIC Mauricie Inc. ( Site 0503)

    Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

Turkey (Türkiye)6 sites

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2613)

    Ankara, 06100

  • I.U. Cerrahpasa Tip Fakultesi Gogus Hastaliklari Anabilim Dali ( Site 2600)

    Fatih, 34098

  • Yedikule Gogus Hast. ve Gogus Cer. Egitim ve Arastirma Hastanesi ( Site 2601)

    Istanbul, 34020

  • Kocaeli Universitesi Tip Fakultesi ( Site 2611)

    Kocaeli, 41380

  • Recep Tayyip Erdogan Universitesi Tip Fakultesi Egitim ve Aras. Has ( Site 2620)

    Rize, 55200

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2606)

    Samsun, 55139

Other trials in Turkey (Türkiye)

France5 sites

  • Hopital Cavale Blanche ( Site 0909)

    Brest, 29609

  • Hopital Nord du Marseille ( Site 0910)

    Marseille, 13015

  • Hopital Arnaud de Villeneuve ( Site 0905)

    Montpellier, 34295

  • CHU Hotel Dieu Nantes ( Site 0906)

    Nantes, 44093

  • CHU de Toulouse - Hopital Larrey ( Site 0900)

    Toulouse, 31100

Other trials in France

Hungary5 sites

  • Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)

    Balassagyarmat, 2660

  • Erzsebet Gondozohaz ( Site 1207)

    Gödöllő, 2100

  • Petz Aladar Megyei Oktato Korhaz ( Site 1206)

    Győr, 9024

  • Synexus Magyarorszag Kft. ( Site 1210)

    Gyula, 5700

  • CRU Hungary KFT ( Site 1205)

    Miskolc, 3529

Other trials in Hungary

Israel5 sites

  • Hillel Yaffe Medical Center ( Site 1303)

    Hadera, 3810101

  • Carmel Medical Center ( Site 1305)

    Haifa, 3436212

  • Meir Medical Center ( Site 1301)

    Kfar Saba, 4428164

  • Rabin Medical Center ( Site 1302)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center. ( Site 1304)

    Ramat Gan, 5265601

Other trials in Israel

Taiwan5 sites

  • Changhua Christian Hospital ( Site 2403)

    Changhua, 50006

  • Chang Gung Medical Foundation - Keelung Branch ( Site 2404)

    Keelung, 20401

  • Far Eastern Memorial Hospital ( Site 2402)

    New Taipei City, 22056

  • Taichung Veterans General Hospital ( Site 2401)

    Taichung, 407

  • National Taiwan University Hospital ( Site 2400)

    Taipei, 10002

Other trials in Taiwan

Czechia4 sites

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

    Brandýs nad Labem, 250 01

  • Plicni ambulance ( Site 0701)

    Rokycany, 337 22

  • Plicni stredisko Teplice s. r. o ( Site 0700)

    Teplice, 415 01

  • Pneumologie Varnsdorf S.R.O. ( Site 0706)

    Varnsdorf, 407 47

Other trials in Czechia

Peru4 sites

  • Hospital Nacional Adolfo Guevara Velasco ( Site 1808)

    Cusco, 08006

  • Asociacion Civil por la Salud ( Site 1805)

    Lima, 15046

  • Hospital Chancay y Servicios Basicos de Salud ( Site 1810)

    Lima, 15131

  • Clinica Ricardo Palma ( Site 1802)

    San Isidro, Lima region, 15036

Other trials in Peru

Spain4 sites

  • Hospital Clinic ( Site 2302)

    Barcelona, 08036

  • Hospital General Universitario Gregorio Maranon ( Site 2309)

    Madrid, 28007

  • Hospital Parc Tauli ( Site 2308)

    Sabadell, 08208

  • Hospital Clinico Universitario de Santiago ( Site 2303)

    Santiago de Compostela, 15706

Other trials in Spain

Denmark3 sites

  • CCBR AS Aalborg, Center for Clinical & Basic Research ( Site 0802)

    Aalborg, 9000

  • Herlev Hospital ( Site 0803)

    Herlev, 2730

  • CCBR AS Vejle, Center for Clinical & Basic Research ( Site 0801)

    Vejle, 7100

Other trials in Denmark

Ukraine3 sites

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

    Kyiv, 03680

  • City Polyclinic N20 ( Site 2822)

    Odesa, 65114

  • Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2815)

    Vinnytsia, 21001

Other trials in Ukraine

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 (PN027)

The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.

Read the detailed description

The study will include a screening period to determine participant inclusion, and the Baseline visit will include 24 hours of objective measurement of cough. The study will consist of two treatment periods, a main 12-week treatment period and a 40-week extension period (52 weeks total treatment), followed by a 14-day telephone follow-up period.

Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 3-month, Off-treatment Durability Study Period, which extends the Estimated Study Completion Date. The Off-treatment Durability Study Period will explore the impact of withdrawing gefapixant in refractory or unexplained chronic cough participants who have been treated for 1 year.

Conditions
Chronic Cough
Being tested
Placebo, Gefapixant
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

    Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.

  • GefapixantDrug

    Also called MK-7264

    Gefapixant 15 mg or 45 mg tablet administered orally BID during the 12-week main study period and during the 40-week extension period, according to randomization.

Study groups in NCT03449134
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants receive dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
Receives: Drug: Placebo
Gefapixant 15 mg BIDExperimentalParticipants receive a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.
Receives: Drug: Placebo; Drug: Gefapixant
Gefapixant 45 mg BIDExperimentalParticipants receive a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.
Receives: Drug: Placebo; Drug: Gefapixant

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 Objective Coughs Per Hour (Week 12/Baseline)

    24-hour objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually <24 hours but ≥20 hours). Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough counts to determine geometric mean (GM) 24-hour objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM 24-hour objective coughs per hour divided by the Baseline GM 24-hour objective coughs per hour was reported for all treatment study arms.

    Measured: Baseline, Week 12

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

    An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with at least one AE during either the 52-week treatment period or 2-week telephone follow-up was reported for all treatment study arms.

    Measured: Up to approximately 54 weeks

  3. Number of Participants Who Discontinued Treatment Due to AEs

    An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention during the 52-week treatment period due to an AE for which the action taken was listed as 'drug withdrawn' was reported for all treatment study arms.

    Measured: Up to approximately 52 weeks

Secondary outcomes (6)

  1. Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline)

    Awake objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) while the participant is awake divided by the total duration (in hours) for the monitoring period that the participant was awake. Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal ANCOVA model was applied to log-transformed cough counts to determine GM awake objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM awake objective coughs per hour divided by the Baseline GM awake objective coughs per hour was reported for all treatment study arms.

    Measured: Baseline, Week 12

  2. Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12

    24-hour coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually <24 hours but ≥20 hours). Assessment based on 24-hour sound recordings using a digital recording device. Percent change in 24-hour coughs per hour = (change from baseline in 24-hour coughs per hour / baseline 24-hour coughs per hour) ×100%. Negative values indicate a decrease in cough rate, while positive values indicate an increase in cough rate. A participant was considered a responder if the percent change from baseline in 24-hour coughs per hour was ≤ -30% (or a ≥30% reduction from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 12 (≥30% reduction from baseline) was reported for all treatment study arms.

    Measured: Baseline, Week 12

  3. Percentage of Participants (Model-Based) With a ≤ -1.3-point Change From Baseline in Mean Weekly Cough Severity Diary (CSD) Total Score at Week 12

    The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores 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 total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -1.3 points (or a ≥1.3 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -1.3 point change from baseline in CSD at Week 12 (or ≥1.3 point reduction from baseline) was reported for all treatment study arms.

    Measured: Baseline, Week 12

  4. Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12

    The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores 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 total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -2.7 points (or a ≥2.7 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -2.7 point change from baseline in CSD at Week 12 (or ≥2.7 point reduction from baseline) was reported for all treatment study arms.

    Measured: Baseline, Week 12

  5. Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12

    Cough severity was scored using the Cough Severity VAS, a single-item question asking the participant to rate the severity of their cough "today" using a 100 mm VAS (100-point scale) ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was derived as the average of VAS scores collected during the week prior to each visit. Baseline was defined as the average VAS scores collected during the week prior to Day 1 (Day -6 to Day 0). A participant was considered a responder if the change from baseline in mean weekly Cough Severity VAS score was ≤-30 mm (or a ≥30 mm reduction from baseline); participants considered non-responders otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with ≤ -30 mm change from baseline in Cough Severity VAS at Week 12 (≥30 mm reduction from baseline) was reported for all treatment study arms.

    Measured: Baseline, Week 12

  6. Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12

    The LCQ assesses the impact of chronic cough on health-related quality of life. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of individual item score within the domain divided by the number of items in the domain. LCQ total score is the sum of the three domain scores and ranges from 3-21; with a higher score corresponding to a better health status. A participant was considered a responder if the change from baseline in LCQ total score was ≥1.3-points (increase from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≥1.3-point change from baseline in LCQ total score at Week 12 was reported for all treatment study arms.

    Measured: Baseline, Week 12

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 start14 Mar 2018
  3. Primary completion5 Jun 2020
  4. Study completion17 Aug 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 during the Treatment Period: Placebo, gefapixant 15 mg twice daily (BID), or gefapixant 45 mg BID. Participants will remain on their assigned treatment throughout the study. A safety follow-up phone call will be conducted at a minimum of 14 days after last dose of study treatment.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03449134
Sponsor's protocol ID
7264-027
Other IDs
MK-7264-027, 2017-000537-31, 184098, 2017
Status last verified
Jun 2021
First submitted
22 Feb 2018
Last updated
16 Jun 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 in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 156 sites in 17 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 14 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 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in Japan, United States, South Korea, United Kingdom, Argentina and 12 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 16 Jun 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 Objective Coughs Per Hour (Week 12/Baseline) (time frame: Baseline, Week 12). 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 NCT03449134, 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 16 Jun 2021.

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