UnknownPhase 1/2

A Phase Ib/II Clinical Study in Patients With Refractory Chronic Cough

72 participantsStarted 2024-02

Plain-language summary

This study is a multicenter, randomized, double-blind, placebo-controlled Phase Ib/II clinical trial to evaluate the effectiveness, safety, tolerability and pharmacokinetics (PK) of TCR1672 Tablets in patients with refractory chronic cough.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female participants who can understand and are willing to complete this trial in strict accordance with the clinical trial protocol, and voluntarily sign the informed consent form;
✓. Age ≥ 18 years (subject to the age specified in the valid document at the time of signing the informed consent form);
✓. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, and BMI \< 35kg/m2;
✓. History of chronic cough for more than 1 year, and definitely diagnosed as refractory chronic cough or chronic cough of unknown cause. See Appendix 2 for the diagnostic criteria;
✓. Chest imaging within 5 years prior to screening and after the onset of chronic cough did not show abnormal changes that in the opinion of the investigator may contribute to the chronic cough;
✓. The 100-mm cough Visual Analogue Scale (VAS) score ≥ 40 mm at screening and baseline;
✓. The cough recorder at screening showed an average of 10 or more coughs per hour while awake;
✓. Participants of childbearing potential and their sexual partners are willing to take one or more effective non-drug contraceptive measures and have no plans to donate sperm or ova from the time of screening until 6 months after the last dose of study drug; Female participants should be non-pregnant and non-lactating, and should meet at least 1 of the following conditions:

Exclusion criteria

✕. Pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \< 70% of the expected value at screening;
✕. History of upper or lower respiratory tract infection (including bacterial, fungal, viral and other pathogenic microorganism infections) or recent significant change in pulmonary conditions (including acute exacerbation of respiratory disease or significant change in chest imaging) within 4 weeks prior to screening or randomization;
✕. Diagnosed as chronic obstructive pulmonary disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis (IPF), active pulmonary tuberculosis before screening;
✕. Past medical history of hypogeusia or taste disorder, or known taste abnormality;
✕. With malignancy within 5 years prior to screening (except adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ);
✕. Moderate renal insufficiency: glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 prior to screening or prior to randomization;
✕. Moderate to severe hepatic insufficiency (Child-Pugh Class B or C) prior to screening or prior to randomization;
✕. History of unstable or worsening cardiovascular disease prior to screening or prior to randomization, including but not limited to: unstable angina, myocardial infarction, thromboembolism;

What they're measuring

Efficacy Endpoint

Timeframe: 1 week

Safety Endpoints

Timeframe: 4 week

Trial details

NCT IDNCT06213363

SponsorBeijing Tide Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10

View on ClinicalTrials.gov More Refractory Chronic Cough trials