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

NCT03449134 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: 7264-027MK-7264-0272017-000537-31184098
• Study Type: interventional
• Target: 732
• Locations: 17 countries
• Sites: 156

Brief 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. 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.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, Week 12

• 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.

  Up to approximately 54 weeks

• 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.

  Up to approximately 52 weeks

Secondary Outcomes (6)

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

  Baseline, Week 12

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

  Baseline, Week 12

• 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

  Baseline, Week 12

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

  Baseline, Week 12

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

  Baseline, Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants receive dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.

Drug: Placebo

Gefapixant 15 mg BID

EXPERIMENTAL

Participants 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.

Drug: Placebo; Drug: Gefapixant

Gefapixant 45 mg BID

EXPERIMENTAL

Participants 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.

Drug: Placebo; Drug: Gefapixant

Interventions

Placebo DRUG

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

Gefapixant 15 mg BID; Gefapixant 45 mg BID; Placebo

Gefapixant DRUG

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.

Also known as: MK-7264

Gefapixant 15 mg BID; Gefapixant 45 mg BID

Eligibility Criteria

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

You may qualify if:

• Chest radiograph or 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (156)

Research Solutions of Arizona PC ( Site 0036)

Litchfield Park, Arizona, 85340, United States

Location

Medical Research of AZ ( Site 0060)

Scottsdale, Arizona, 85251, United States

Location

Biosolutions Clinical Research Center ( Site 0070)

La Mesa, California, 91942, United States

Location

Center for Clinical Trials, LLC ( Site 0059)

Paramount, California, 90723, United States

Location

Sher Allergy Specialists/Center For Cough ( Site 0078)

Largo, Florida, 33778, United States

Location

Well Pharma Medical Research, Corp. ( Site 0093)

Miami, Florida, 33143, United States

Location

Florida Pulmonary Research Institute, LLC ( Site 0019)

Winter Park, Florida, 32789, United States

Location

Midwest Allergy Sinus Asthma, SC ( Site 0081)

Normal, Illinois, 61761, United States

Location

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

Topeka, Kansas, 66606, United States

Location

BreatheAmerica Inc ( Site 0048)

Shreveport, Louisiana, 71106, United States

Location

Clinical Research Institute LLC ( Site 0004)

Minneapolis, Minnesota, 55402, United States

Location

The Center for Pharmaceutical Research PC ( Site 0016)

Kansas City, Missouri, 64114, United States

Location

American Health Research ( Site 0082)

Charlotte, North Carolina, 28207, United States

Location

Clinical Research of Gastonia ( Site 0043)

Gastonia, North Carolina, 28054, United States

Location

Bernstein Clinical Research Center, LLC ( Site 0005)

Cincinnati, Ohio, 45231, United States

Location

Vital Prospects Clinical Research Institute, PC ( Site 0037)

Tulsa, Oklahoma, 74136, United States

Location

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

East Providence, Rhode Island, 02914, United States

Location

Sirius Clinical Research, LLC ( Site 0102)

Austin, Texas, 78759, United States

Location

Pharmaceutical Research & Consulting, Inc. ( Site 0029)

Dallas, Texas, 75231, United States

Location

Mainland Medical Research Institute ( Site 0003)

Dickinson, Texas, 77539, United States

Location

Diagnostics Research Group ( Site 0035)

San Antonio, Texas, 78229, United States

Location

Allergy & Asthma Center ( Site 0001)

Waco, Texas, 76712, United States

Location

Intermountain Clinical Research ( Site 0033)

Draper, Utah, 84020, United States

Location

Charlottesville Medical Research Center, LLC ( Site 0006)

Charlottesville, Virginia, 22911, United States

Location

Pulmonary Associates of Richmond Inc. ( Site 0101)

Richmond, Virginia, 23225, United States

Location

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

Richmond, Virginia, 23294, United States

Location

Lung and Sleep Specialists ( Site 0091)

Williamsburg, Virginia, 23188, United States

Location

InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)

Caba, Buenos Aires, C1425BEN, Argentina

Location

Fundacion CIDEA ( Site 0323)

Ciudad de Buenos Aires, Buenos Aires, C1121ABE, Argentina

Location

Instituto Ave Pulmo ( Site 0322)

Mar del Plata, Buenos Aires, B7602DCK, Argentina

Location

Centro Medico Privado de Reumatologia ( Site 0309)

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Investigaciones en Patologias Respiratorias ( Site 0325)

San Miguel de Tucumán, Tucumán Province, T4000IAR, Argentina

Location

CEMEDIC - Centro de Especialidades Medicas ( Site 0304)

Buenos Aires, C1407GTN, Argentina

Location

Centro Medico Dra De Salvo ( Site 0310)

Buenos Aires, C1426ABP, Argentina

Location

Hospital Privado Universitario de Cordoba ( Site 0313)

Córdoba, X5016KEH, Argentina

Location

Fundacion Scherbovsky ( Site 0300)

Mendoza, M5500AXR, Argentina

Location

Canadian Phase Onward Inc. ( Site 0509)

Toronto, Ontario, M3J 2C5, Canada

Location

Recherche GCP Research ( Site 0500)

Montreal, Quebec, H1M 1B1, Canada

Location

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

Montreal, Quebec, H3G 1L5, Canada

Location

Dynamik Research ( Site 0505)

Pointe-Claire, Quebec, H9R 3J1, Canada

Location

Diex Recherche Quebec Inc ( Site 0515)

Québec, Quebec, G1N 4V3, Canada

Location

Q & T Research Sherbrooke Inc. ( Site 0512)

Sherbrooke, Quebec, J1J 2G2, Canada

Location

CIC Mauricie Inc. ( Site 0503)

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

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

Brandýs nad Labem, 250 01, Czechia

Location

Plicni ambulance ( Site 0701)

Rokycany, 337 22, Czechia

Location

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

Teplice, 415 01, Czechia

Location

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

Varnsdorf, 407 47, Czechia

Location

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

Aalborg, 9000, Denmark

Location

Herlev Hospital ( Site 0803)

Herlev, 2730, Denmark

Location

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

Vejle, 7100, Denmark

Location

Hopital Cavale Blanche ( Site 0909)

Brest, 29609, France

Location

Hopital Nord du Marseille ( Site 0910)

Marseille, 13015, France

Location

Hopital Arnaud de Villeneuve ( Site 0905)

Montpellier, 34295, France

Location

CHU Hotel Dieu Nantes ( Site 0906)

Nantes, 44093, France

Location

CHU de Toulouse - Hopital Larrey ( Site 0900)

Toulouse, 31100, France

Location

Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)

Balassagyarmat, 2660, Hungary

Location

Erzsebet Gondozohaz ( Site 1207)

Gödöllő, 2100, Hungary

Location

Petz Aladar Megyei Oktato Korhaz ( Site 1206)

Győr, 9024, Hungary

Location

Synexus Magyarorszag Kft. ( Site 1210)

Gyula, 5700, Hungary

Location

CRU Hungary KFT ( Site 1205)

Miskolc, 3529, Hungary

Location

Hillel Yaffe Medical Center ( Site 1303)

Hadera, 3810101, Israel

Location

Carmel Medical Center ( Site 1305)

Haifa, 3436212, Israel

Location

Meir Medical Center ( Site 1301)

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center ( Site 1302)

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center. ( Site 1304)

Ramat Gan, 5265601, Israel

Location

National Hospital Organization Nagoya Medical Center ( Site 1539)

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya City University Hospital ( Site 1528)

Nagoya, Aichi-ken, 467-8602, Japan

Location

National Hospital Organization Ehime Medical Center ( Site 1556)

Tōon, Ehime, 791-0281, Japan

Location

Idaimae Minamiyojo Int Clinic ( Site 1521)

Sapporo, Hokkaido, 064-0804, Japan

Location

Terada Clinic Respiratory Medicine & General Practice ( Site 1565)

Himeji, Hyōgo, 670-0849, Japan

Location

Kinki Central Hospital ( Site 1576)

Itami, Hyōgo, 664-8533, Japan

Location

Itami City Hospital ( Site 1580)

Itami, Hyōgo, 664-8540, Japan

Location

National Hospital Organization Ibarakihigashi National Hospital ( Site 1526)

Naka-gun, Ibaraki, 319-1113, Japan

Location

Ishikawa Prefectural Central Hospital ( Site 1554)

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Kanazawa University Hospital ( Site 1536)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Komatsu Municipal Hospital ( Site 1508)

Komatsu, Ishikawa-ken, 923-8560, Japan

Location

Kamei Internal Medicine and Respiratory Clinic ( Site 1509)

Takamatsu, Kagawa-ken, 761-8073, Japan

Location

Fujisawa City Hospital ( Site 1505)

Fujisawa, Kanagawa, 251-8550, Japan

Location

Yokohama City Minato Red Cross Hospital ( Site 1506)

Yokohama, Kanagawa, 231-8682, Japan

Location

Medical Corporation Shintokai Yokohama Minoru Clinic ( Site 1568)

Yokohama, Kanagawa, 232-0064, Japan

Location

Saiseikai Yokohamashi Nanbu Hospital ( Site 1533)

Yokohama, Kanagawa, 234-8503, Japan

Location

Kanagawa Cardiovascular and Respiratory Center ( Site 1503)

Yokohama, Kanagawa, 236-0051, Japan

Location

Matsusaka City Hospital ( Site 1525)

Matsusaka, Mie-ken, 515-8544, Japan

Location

Nagaoka Red Cross Hospital ( Site 1507)

Nagaoka, Niigata, 940-2085, Japan

Location

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

Tsukubo-gun, Okayama-ken, 701-0304, Japan

Location

Urasoe General Hospital ( Site 1572)

Urasoe, Okinawa, 901-2132, Japan

Location

Osaka Habikino Medical Center ( Site 1546)

Habikino, Osaka, 583-8588, Japan

Location

Kawaguchi Respiratory Clinic ( Site 1504)

Higashiosaka, Osaka, 577-0843, Japan

Location

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

Sakai, Osaka, 591-8555, Japan

Location

Tokyo Medical University Hachioji Medical Center ( Site 1569)

Hachiōji, Tokyo, 193-0998, Japan

Location

National Hospital Organization Tokyo National Hospital ( Site 1557)

Kiyose, Tokyo, 204-8585, Japan

Location

National Hospital Organization Disaster Medical Center ( Site 1558)

Tachikawa, Tokyo, 190-0014, Japan

Location

Shimonoseki City Hospital ( Site 1573)

Shimonoseki, Yamaguchi, 750-8520, Japan

Location

National Hospital Organization Fukuoka Hospital ( Site 1552)

Fukuoka, 811-1394, Japan

Location

Hiroshima Allergy & Respiratory Clinic ( Site 1529)

Hiroshima, 732-0052, Japan

Location

Kyoto University Hospital ( Site 1547)

Kyoto, 606-8507, Japan

Location

JA Niigatakoseiren Niigata Medical Center ( Site 1522)

Niigata, 950-2022, Japan

Location

Shizuoka Prefectural Hospital Organization Shizuoka General Hospital ( Site 1524)

Shizuoka, 420-8527, Japan

Location

Juntendo University Hospital ( Site 1578)

Tokyo, 113-8431, Japan

Location

Tokyo Shinagawa Hospital ( Site 1560)

Tokyo, 140-8522, Japan

Location

Showa University Hospital ( Site 1531)

Tokyo, 142-8666, Japan

Location

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

Tokyo, 162-8655, Japan

Location

Tokyo Metropolitan Geriatric Hospital ( Site 1577)

Tokyo, 173-0015, Japan

Location

Clinica Ricardo Palma ( Site 1802)

San Isidro, Lima region, 15036, Peru

Location

Hospital Nacional Adolfo Guevara Velasco ( Site 1808)

Cusco, 08006, Peru

Location

Asociacion Civil por la Salud ( Site 1805)

Lima, 15046, Peru

Location

Hospital Chancay y Servicios Basicos de Salud ( Site 1810)

Lima, 15131, Peru

Location

Prywatny Gabinet Internistyczno ( Site 1928)

Bialystok, 15-010, Poland

Location

Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)

Bialystok, 15-044, Poland

Location

Centrum Medyczne Pratia Bydgoszcz ( Site 1418)

Bydgoszcz, 85-796, Poland

Location

Centrum Medyczne Pratia Czestochowa ( Site 1926)

Częstochowa, 42-200, Poland

Location

Centrum Medyczne Pratia Gdynia ( Site 1910)

Gdynia, 81-338, Poland

Location

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

Krakow, 30-033, Poland

Location

USK nr 1 ( Site 1921)

Lodz, 90-153, Poland

Location

Prywatny Gabinet Specjalistyczny ( Site 1927)

Lodz, 91-849, Poland

Location

NZOZCentrum Medyczne Kermed ( Site 1905)

Żnin, 88-400, Poland

Location

Wonju Severance Christian Hospital ( Site 2214)

Wŏnju, Gangwon-do, 26426, South Korea

Location

Hallym University Sacred Heart Hospital ( Site 2208)

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Ajou University Hospital ( Site 2211)

Suwon, Gyeonggi-do, 16499, South Korea

Location

Incheon St. Mary s Hospital ( Site 2200)

Incheon, 21431, South Korea

Location

Seoul National University Hospital ( Site 2210)

Seoul, 03080, South Korea

Location

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

Seoul, 03312, South Korea

Location

Severance Hospital ( Site 2204)

Seoul, 03722, South Korea

Location

Konkuk University Medical Center ( Site 2205)

Seoul, 05030, South Korea

Location

Asan Medical Center ( Site 2203)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 2212)

Seoul, 06351, South Korea

Location

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

Seoul, 06591, South Korea

Location

Korea University Guro Hospital ( Site 2213)

Seoul, 08308, South Korea

Location

Hospital Clinic ( Site 2302)

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon ( Site 2309)

Madrid, 28007, Spain

Location

Hospital Parc Tauli ( Site 2308)

Sabadell, 08208, Spain

Location

Hospital Clinico Universitario de Santiago ( Site 2303)

Santiago de Compostela, 15706, Spain

Location

Changhua Christian Hospital ( Site 2403)

Changhua, 50006, Taiwan

Location

Chang Gung Medical Foundation - Keelung Branch ( Site 2404)

Keelung, 20401, Taiwan

Location

Far Eastern Memorial Hospital ( Site 2402)

New Taipei City, 22056, Taiwan

Location

Taichung Veterans General Hospital ( Site 2401)

Taichung, 407, Taiwan

Location

National Taiwan University Hospital ( Site 2400)

Taipei, 10002, Taiwan

Location

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2613)

Ankara, 06100, Turkey (Türkiye)

Location

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

Fatih, 34098, Turkey (Türkiye)

Location

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

Istanbul, 34020, Turkey (Türkiye)

Location

Kocaeli Universitesi Tip Fakultesi ( Site 2611)

Kocaeli, 41380, Turkey (Türkiye)

Location

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

Rize, 55200, Turkey (Türkiye)

Location

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2606)

Samsun, 55139, Turkey (Türkiye)

Location

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

Kyiv, 03680, Ukraine

Location

City Polyclinic N20 ( Site 2822)

Odesa, 65114, Ukraine

Location

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

Vinnytsia, 21001, Ukraine

Location

Royal Preston Hospital ( Site 2709)

Preston, Lancashire, PR2 9HT, United Kingdom

Location

Medinova Lakeside Dedicated Research Centre ( Site 2710)

Corby, Northamptonshire, NN17 2UR, United Kingdom

Location

Belfast City Hospital ( Site 2705)

Belfast, BT9 7AB, United Kingdom

Location

Broomfield Hospital ( Site 2722)

Chelmsford, CM1 7ET, United Kingdom

Location

Glenfield Hospital ( Site 2701)

Leicester, LE3 9QP, United Kingdom

Location

Royal Brompton Hospital ( Site 2703)

London, SW3 6JY, United Kingdom

Location

Wythenshawe Hospital ( Site 2700)

Manchester, M23 9LT, United Kingdom

Location

Churchill Hospital ( Site 2706)

Oxford, OX3 7LE, United Kingdom

Location

Rothwell Medical Centre ( Site 2712)

Rothwell, NN14 6JQ, United Kingdom

Location

MeDiNova Yorkshire Dedicated Research Centre ( Site 2708)

Shipley, BD18 3SA, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35569802 DERIVED

• 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.

  PMID: 35248186 DERIVED

MeSH Terms

Conditions

Chronic Cough

Interventions

Gefapixant

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: March 14, 2018
• Primary Completion: June 5, 2020
• Study Completion: August 17, 2020
• Last Updated: June 16, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

HU (5); JP (38); ES (4); US (27); KR (12); TW (5); GB (10); TU (6); AR (9); IL (5); PL (9); CA (7); CZ (4); UA (3); DK (3); PE (4); FR (5)