Refractory chronic cough
Conditions
Sponsors
SHIONOGI & CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: -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.
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: -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 symptoms (excluding cough). -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy -Change in cough at Week 4 calculated as the ratio of number of coughs per hour in 24 hours at Week 4 to Baseline [Time Frame:Baseline and Week 4] The number of coughs per hour for 24 hours will be measured using a cough monitor. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy -Percentage of participants with a reduction from baseline in the number of coughs per hour in 24 hours by >=30% [Time Frame:Baseline and Week 4] -Percentage of participants with a reduction from baseline in the number of coughs per hour in 24 hours by >=50% [Time Frame:Baseline and Week 4] -Percentage of participants with a reduction from baseline in the number of coughs per hour in 24 hours by >=70% [Time Frame:Baseline and Week 4] -Change in cough at Week 4 calculated as the ratio of the number of coughs per hour while awake at Week 4 to Baseline [Time Frame:Baseline and Week 4] -Percentage of participants with a reduction from baseline in the number of coughs per hour while awake >=30% [Time Frame:Baseline and Week 4] -Percentage of participants with a reduction from baseline in the number of coughs per hour while awake >=50% [Time Frame:Baseline and Week 4] -Percentage of participants with a reduction from baseline in the number of coughs per hour while awake >=70% [Time Frame:Baseline and Week 4] -Change in cough at Week 4 calculated as the ratio of the number of coughs per hour while asleep at Week 4 to Baseline [Time Frame:Baseline and Week 4] -Change from baseline in weekly cough severity [Time Frame:Baseline and Week 4] -Change from baseline through Day 7 in daily cough severity [Time Frame:Baseline and Day 7] -Change form baseline in Leicester Cough Questionnaire(LCQ) [Time Frame:Baseline and Week 4] -Percentage of participants with an increase in LCQ of >=1.3 points [Time Frame:Baseline and Week 4] -Change form baseline in International Consultation on Incontinence Modular Questionnaire Short Form (ICIQ-SF) [Time Frame:Baseline and Week 4] -Change form baseline in Short Form (36) Health Survey (SF-36) [Time Frame: Baseline and Week 4] -Patient Global Impression of Change (PGIC) [Time Frame: Week 4] | — |
Countries
Europe, Japan, North America
Outcome results
None listed