Phase 2
N=406
Evaluation of S-600918 in Adults With Refractory Chronic Cough
Chronic Cough
Bottom Line
View on ClinicalTrials.gov: NCT04110054 ↗Enrolled (actual)
406
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment — -55.16; -61.08; -65.32; -60.38 percentage change — p=0.9334
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- S-600918 (Drug); Placebo to S-600918 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shionogi
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment |
-55.16; -61.08; -65.32; -60.38 | 0.9334 |
| SECONDARY Number of Participants With 30%, 50%, and 70% Reduction in Number of Coughs Per Hour Over 24 Hours After 4 Weeks of Study Treatment |
55; 66; 66; 61; 38; 46 | — |
| SECONDARY Percent Change in Number of Coughs Per Hour While Awake Following 4 Weeks of Study Treatment |
-55.77; -61.75; -66.33; -60.31 | — |
| SECONDARY Number of Participants With 30%, 50% and 70% Reduction in Number of Coughs Per Hour While Awake After 4 Weeks of Study Treatment |
55; 67; 67; 61; 41; 48 | — |
| SECONDARY Percent Change in Number of Coughs Per Hour While Asleep Following 4 Weeks of Study Treatment |
-54.43; -53.17; -65.48; -52.73 | — |
| SECONDARY Change From Baseline in Weekly Cough Severity Following 4 Weeks of Study Treatment |
-19.99; -22.95; -28.29; -21.74 | — |
| SECONDARY Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score |
2.80; 3.10; 3.86; 3.17 | — |
| SECONDARY Number of Responders Defined as Participants With an Increase in LCQ of ≥ 1.3 Points |
53; 56; 60; 48 | — |
| SECONDARY Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) |
9.9; 8.8; 9.2; 8.6; -2.2; -1.2 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) |
38.4; 38.6; 38.1; 37.8; -0.3; -0.9 | — |
| SECONDARY Number of Responders as Assessed by Patient Global Impression of Change (PGIC) |
57; 72; 79; 65 | — |
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.
Eligibility 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.
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04110054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.