A Study of HS-10383 in Chinese Adult Subjects With Refractory or Unexplained Chronic Cough (RUCC) (NCT06246565) | Clinical Trial Compass
UnknownPhase 2
A Study of HS-10383 in Chinese Adult Subjects With Refractory or Unexplained Chronic Cough (RUCC)
276 participantsStarted 2024-03-01
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HS-10383 in Chinese adult subjects with refractory or unexplained chronic cough (RUCC).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects should have a full understanding of the study contents, process, and possible adverse reactions, and voluntarily sign the informed consent form;
. Subjects aged 18-70 years (including the critical value) with RUCC ≥1 year (diagnosis of RUCC according to the Expert Consensus on Diagnosis and Treatment of Refractory Chronic Cough in China \[Released in 2021\]);
. Subjects whose serum pregnancy test is negative in both screening and baseline visits;
Exclusion criteria
. Subjects who are diagnosed with chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis and other serious lung diseases;
. Any physiological or mental disease or condition that may increase study risks or interfere with the conduct of the study or affect the ability to complete this study in the opinion of the investigator, such as medical history of depression;
. Subjects who cannot meet the requirements for piror treatment or who cannot adhere to the concomitant treatment as specified in Section 6.7-Prior/concomitant medications and non-drug treatment.
. Subjects with positive hepatitis A IgM antibody, hepatitis C antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody at screening visit; subjects with positive hepatitis B surface antigen (HBsAg) at screening (except for quantitative detection result of HBV-DNA is below the lower limit of the detection reference range).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Any former smoker with more than 20 packs/year; or have quited smoking for less than 6 months; or subjects who are still smoking (including e-cigarettes);
. Subjects who have a history of serious drug, food or environmental allergies, or who are known to be allergic to the ingredients of investigational product;
. History of drug dependence,drug or alcohol abuse in the past year;
. Female subjects who are pregnant or breastfeeding;