Evaluation of S-600918 in Adults With Refractory Chronic Cough
- Conditions
- Chronic Cough
- Interventions
- Drug: S-600918Drug: Placebo to S-600918
- Registration Number
- NCT04110054
- Lead Sponsor
- Shionogi
- Brief Summary
The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
- Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
- If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
- Capable of giving signed informed consent.
Key
- Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
- Has chronic obstructive pulmonary disease or uncontrolled asthma.
- Has a clinically unstable medical condition.
- History of or ongoing significant psychiatric disorder.
- History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
- History of malignancy in the last 5 years.
- History of severe drug allergy.
- History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
- Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
- Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
- Received S-600918 previously.
- Received an investigational drug in the last 3 months.
- Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
- Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
- If female, pregnant or trying to become pregnant or breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S-600918 300 mg S-600918 Participants will receive 300 mg S-600918 orally once a day for 28 days. Placebo Placebo to S-600918 Participants will receive placebo to S-600918 orally once a day for 28 days. S-600918 50 mg S-600918 Participants will receive 50 mg S-600918 orally once a day for 28 days. S-600918 150 mg S-600918 Participants will receive 150 mg S-600918 orally once a day for 28 days.
- Primary Outcome Measures
Name Time Method Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment Baseline to Week 4 Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour in 24 hours at each visit with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the log-transformed coughs per hour in 24 hours at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.
- Secondary Outcome Measures
Name Time Method Number of Participants With 30%, 50%, and 70% Reduction in Number of Coughs Per Hour Over 24 Hours After 4 Weeks of Study Treatment Baseline to Week 4 The number of coughs per hour for 24 hours was measured using a cough monitor.
Percent Change in Number of Coughs Per Hour While Awake Following 4 Weeks of Study Treatment Baseline to Week 4 Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour while awake at each visit with treatment, week, and treatment-by-week as fixed effect, participants as random effect, and region and the log-transformed coughs per hour while awake at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.
Number of Participants With 30%, 50% and 70% Reduction in Number of Coughs Per Hour While Awake After 4 Weeks of Study Treatment Baseline to Week 4 The number of coughs per hour while awake was measured using a cough monitor.
Percent Change in Number of Coughs Per Hour While Asleep Following 4 Weeks of Study Treatment Baseline to Week 4 Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour while asleep at each visit with treatment, week, and treatment-by-week as fixed effect, participants as random effect, and region and the log-transformed coughs per hour while asleep at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.
Change From Baseline in Weekly Cough Severity Following 4 Weeks of Study Treatment Baseline to Week 4 Cough severity was assessed by the participant by a visual analog scale with numbers from 0 to 100. Results are presented as change from baseline. Reported change is based on a mixed model for the change in weekly cough severity score after 4 weeks of treatment with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the severity score at baseline as covariates. Higher scores indicated higher cough severity.
Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score Baseline to Week 4 The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the participant responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 21. Higher score indicates a better quality of life. Results are presented as change from baseline. Reported change is based on a mixed model for the change in LCQ Total Score after 4 weeks of treatment with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the LCQ Score of corresponding domain at baseline as covariates.
Number of Responders Defined as Participants With an Increase in LCQ of ≥ 1.3 Points Baseline to Week 4 The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the participant responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 2. A higher score indicates a better quality of life.
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) Baseline to Week 4 The ICIQ-SF is a questionnaire used to evaluate the frequency, severity, and impact of urinary incontinence on the quality of life. The questionnaire includes 3 items with responses measured on Likert scales, and 1 item that is measured via a qualitative response. The 3 nominal responses are summed to give the ICIQ score (this total ICIQ-SF score can range from 0 to 21), where a higher score indicates more severe symptoms. The 1 item remaining that is measured via qualitative response is not given a score; rather, the participant selects 1 description out of 8 possible descriptions of this item.
Change From Baseline in Short Form (36) Health Survey (SF-36) Baseline to Week 4 The SF-36 is a 36-item questionnaire to assesses a participant's health status using 8 health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The mental component reports the average of all the emotionally relevant items and the physical component reports the average of all the physically relevant items. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 indicates no disability. Median change can range from -100 to 100. A positive median change indicates an improved outcome.
Number of Responders as Assessed by Patient Global Impression of Change (PGIC) Week 4 The PGIC is a patient-reported measure of overall health status and consists of 1 item adapted from the Clinical Global Impressions scale. The participant selects 1 description out of 7 possible descriptions of this item. The descriptions are numbered from 1 through 7, where lower numbers indicate better quality of life. Participants were considered responders if they reported "Very much improved", "Much improved", or "Minimally improved" from baseline on the PGIC assessment.
Trial Locations
- Locations (135)
Research Solutions of Arizona
🇺🇸Litchfield Park, Arizona, United States
Allergy & Asthma Associates of Southern California dba Southern California Research
🇺🇸Mission Viejo, California, United States
Medical Research Of Central Florida, LLC
🇺🇸Leesburg, Florida, United States
Lenus Research & Medical Group, LLC
🇺🇸Sweetwater, Florida, United States
Sneeze, Wheeze, & Itch Associates, LLC
🇺🇸Normal, Illinois, United States
Abraham Research PLLC
🇺🇸Fort Mitchell, Kentucky, United States
Clayton Sleep Institute, LLC
🇺🇸Saint Louis, Missouri, United States
ADAC Research, PA
🇺🇸Greenville, South Carolina, United States
University of Missouri Hospital and Clinics, Hearing and Balance Center
🇺🇸Columbia, Missouri, United States
Southeastern Research Center
🇺🇸Winston-Salem, North Carolina, United States
Plicní středisko Teplice s.r.o.
🇨🇿Teplice, Czechia
Atlantic Research Center, LLC
🇺🇸Ocean City, New Jersey, United States
Respiratory Clinical Trials
🇬🇧Cottingham, East Yorkshire, United Kingdom
Alliance for Multispecialty Research
🇺🇸Tempe, Arizona, United States
Southern California Institute For Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Shionogi Research Site
🇺🇸Bangor, Maine, United States
Minnesota Lung Center
🇺🇸Woodbury, Minnesota, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
St. Joseph's Hospital
🇺🇸Bangor, Maine, United States
Clinical Research Associates of Central PA, LLC
🇺🇸DuBois, Pennsylvania, United States
Pharmaceutical Research & Consulting, Inc
🇺🇸Dallas, Texas, United States
MeDiNova South London Quality Research Site
🇬🇧Sidcup, Kent, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Mazda Hospital of Mazda Motor Corporation
🇯🇵Aki-gun, Hiroshima, Japan
Tohno Chuo Clinic
🇯🇵Mizunami-shi, Gifu, Japan
Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
🇯🇵Fukuyama, Hiroshima, Japan
Makita Hospital
🇯🇵Sapporo-city, Hokkaido, Japan
Hitachi, Ltd. Hitachinaka General Hospital
🇯🇵Hitachinaka-shi, Ibaraki, Japan
National Hospital Organization Ibarakihigashi National Hospital
🇯🇵Naka-gun, Ibaraki, Japan
National Hospital Organization Sagamihara National Hospital
🇯🇵Sagamihara-shi, Kanagawa, Japan
Shimonoseki City Hospital
🇯🇵Shimonoseki-shi, Yamaguchi, Japan
Mayo Clinic, Division of Pulmonary and Critical Care Medicine
🇺🇸Rochester, Minnesota, United States
Creighton University Clinical Research Office
🇺🇸Omaha, Nebraska, United States
Pulmonary Associates, PA
🇺🇸Phoenix, Arizona, United States
Institute of HealthCare Assessment, Inc.
🇺🇸San Diego, California, United States
Northwest Research Center
🇺🇸Portland, Oregon, United States
Mayo Clinic Pulmonary Clinical Research Unit
🇺🇸Rochester, Minnesota, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
MCA Research
🇺🇸Houston, Texas, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Sher Allergy Specialist/Center for Cough
🇺🇸Largo, Florida, United States
California Medical Research Associates, Inc.
🇺🇸Northridge, California, United States
University of Kansas Medical Center-Hospital
🇺🇸Kansas City, Kansas, United States
University of Missouri Hospital and Clinics, ENT & Allergy Center of Missouri
🇺🇸Columbia, Missouri, United States
University of Missouri Hospital - Clinical Research Center
🇺🇸Columbia, Missouri, United States
Montana Medical Research, Inc.
🇺🇸Missoula, Montana, United States
Associated Specialists in Medicine, PC
🇺🇸Saint Louis, Missouri, United States
The Clinical Research Center, LLC
🇺🇸Saint Louis, Missouri, United States
American Health Research Inc
🇺🇸Charlotte, North Carolina, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
AAPRI Clinical Research Institute
🇺🇸Warwick, Rhode Island, United States
Clinical Research of Rock Hill
🇺🇸Rock Hill, South Carolina, United States
Allergy and Asthma Care of Waco
🇺🇸Waco, Texas, United States
Metroplex Pulmonary and Sleep Center
🇺🇸McKinney, Texas, United States
Allergy Asthma Research Institute
🇺🇸Waco, Texas, United States
Intermountain Clinical Research
🇺🇸Draper, Utah, United States
Allergy, Asthma & Sinus Center, S.C.
🇺🇸Greenfield, Wisconsin, United States
Fakultní Nemocnice Olomouc
🇨🇿Olomouc, Czech Republic, Czechia
Tidewater Physicians Multispecialty Group Clinical Research
🇺🇸Williamsburg, Virginia, United States
MUDr. Jaroslav Mareš -
🇨🇿Strakonice, Czechia
MUDr. I. Čierná-Peterová s.r.o.
🇨🇿Brandýs nad Labem-Stará Boleslav, Czechia
Plicní Ambulance Rokycany s.r.o.
🇨🇿Rokycany, Czechia
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Fukui Prefectural Hospital
🇯🇵Fukui-shi, Fukui, Japan
Pneumologie Varnsdorf s.r.o.
🇨🇿Varnsdorf, Czechia
Nishi Fukuoka Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima-shi, Fukushima, Japan
Iizuka Hospital
🇯🇵Iizuka, Fukuoka, Japan
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
🇯🇵Fukuoka City, Fukuoka, Japan
Idaimae Minamiyojo Int Clinic
🇯🇵Sapporo, Hokkaido, Japan
Nakatani Hospital
🇯🇵Himeji, Hyogo, Japan
Kobe University Hospital
🇯🇵Kobe City, Hyogo, Japan
Sakaide City Hospital
🇯🇵Sakaide-shi, Kagawa, Japan
Kamei Internal Medicine and Respiratory Clinic
🇯🇵Takamatsu, Kagawa, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa-shi, Ishikawa, Japan
Fujisawa City Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
🇯🇵Yokohama-shi, Kanagawa, Japan
Kyoto University Hospital
🇯🇵Kyoto-shi, Kyoto, Japan
Lee's Clinic
🇯🇵Osaka-shi, Osaka, Japan
Tohoku Rosai Hospital
🇯🇵Sendai-City, Miyagi, Japan
Shizuoka General Hospital
🇯🇵Shizuoka-shi, Shizuoka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
🇯🇵Sakai-shi, Osaka, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Senzoku Kokyuuki Allergy Clinic
🇯🇵Ota-ku, Tokyo, Japan
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
🇯🇵Shinagawa-ku, Tokyo, Japan
Prywatny Gabinet lnternistyczno-Alergologiczny
🇵🇱Bialystok, Poland
Centrum Medyczne Pratia Gdynia
🇵🇱Gdynia, Poland
Centrum Medyczne Pratia Bydgoszcz
🇵🇱Bydgoszcz, Poland
Centrum Medyczne Silmedic Sp. z o. o.
🇵🇱Katowice, Poland
Gyncentrum Sp. Z o. o.
🇵🇱Katowice, Poland
Diamond Clinic
🇵🇱Krakow, Poland
Centrum Alergologii Teresa Hofman Sp. Z o.o.
🇵🇱Poznan, Poland
Poradnia Alergologiczna SPZOZ USK nr 1 UM w Lodzi
🇵🇱Lodz, Poland
RCMed Oddz. Sochaczew
🇵🇱Sochaczew, Poland
Centrum Medyczne Lucyna Andrzej Dymek
🇵🇱Strzelce Opolskie, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska
🇵🇱Tarnow, Poland
Chernihiv City Hospital #2, Therapy Department
🇺🇦Chernihiv, Ukraine
City Clinical Hospital #13
🇺🇦Kharkiv, Ukraine
Communal Non-profit Enterprise "Kherson City Clinical Hospital named after Ye. Ye. Karabelesh" of the Kherson City Council, Pulmonary Therapeutic Department
🇺🇦Kherson, Ukraine
Medical Center of LLC Medical Clinic Blagomed
🇺🇦Kyiv, Ukraine
Medical Center of Edelweiss Medics LLC , Treatment and Prevention Department
🇺🇦Kyiv, Ukraine
Municipal Non-commercial Enterprise "Consultative-Diagnostics Center" of Desnyanskyi District of Kyiv, Therapy Department
🇺🇦Kyiv, Ukraine
Medical Center of LLC Medbud-Clinic, Treatment and Prevention Department
🇺🇦Kyiv, Ukraine
National Institute of Phthisiology and Pulmonology, Department of Pulmonology
🇺🇦Kyiv, Ukraine
Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail, Department of Pulmonology
🇺🇦Kyiv, Ukraine
Clinic of SI National Research Centre of Radiation Medicine of NAMS of Ukraine, Unit of Pulmonology of Department of Therapy of Radiation Consequences of Clinical Radiology Institute
🇺🇦Kyiv, Ukraine
Wythenshawe Hospital
🇬🇧Manchester, Greater Manchester, United Kingdom
BMI Bishops Wood Hospital
🇬🇧Northwood, Middlesex, United Kingdom
MeDiNova North London Quality Research Site
🇬🇧Northwood, Middlesex, United Kingdom
Medinova Research Northamptonshire Quality Research Site
🇬🇧Corby, Northamptonshire, United Kingdom
Belfast City Hospital
🇬🇧Belfast, United Kingdom
West Walk Surgery
🇬🇧Yate, United Kingdom
Yokohama City Minato Red Cross Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Medinova Yorkshire Quality Research Site
🇬🇧Bradford, West Yorkshire, United Kingdom
Yoga Allergy Clinic
🇯🇵Setagaya, Tokyo, Japan
Koukokukai Ebisu Clinic
🇯🇵Shibuya-shi, Tokyo, Japan
Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital
🇬🇧North Shields, Northumberland, United Kingdom
Kouwakai Kouwa Clinic
🇯🇵Toshima-ku, Tokyo, Japan
Ostrowieckie CM S.C. A. Olech-Cudzik, K. Cudzik
🇵🇱Ostrowiec Swietokrzyski, Poland
KONO Medical Clinic
🇯🇵Setagaya-ku, Tokyo, Japan
Nihonbashi Medical & Allergy Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Centrum Medycyny Oddechowej Mroz sp. j.
🇵🇱Bialystok, Poland
Takahashi Medical Clinic
🇯🇵Kokubunji-shi, Tokyo, Japan
SI "National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine," Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Diseases
🇺🇦Kyiv, Ukraine
The 1st City Clinical Hospital of Poltava City Council
🇺🇦Poltava, Ukraine
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital, Pulmonary-Allergological Department with Immunological and Therapeutic Beds
🇺🇦Kharkiv, Ukraine
CNE Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC, Regional Treatment and Diagnostic Pulmonology Center, Chair of Internal Medicine #1, Vinnytsia National Medical University n.a.M.I.Pyrogov
🇺🇦Vinnytsia, Ukraine
Medical and Sanitary Unit of Private Joint Stock Company Kharkiv Tractor Plant, Therapeutic Department, Kharkiv Medical Academy of Postgraduate Education, Chair of General Practice-family Medicine
🇺🇦Kharkiv, Ukraine
Municipal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council, Pulmonology Department
🇺🇦Lutsk, Ukraine
Small Business Private Enterprise Medical Centre "Pulse", Therapeutic Department
🇺🇦Vinnytsya, Ukraine
Montefiore Medical Center
🇺🇸Bronx, New York, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States