refractory chronic cough
Conditions
Interventions
treatment group:Crisugabalin treatment
control group:Oral blank placebo identical in appearance to cligasibalin.
Oral blank placebo identical in appearance to cligasibalin.
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 70 years; (2) Patients with refractory chronic cough who, after comprehensive examination based on the chronic cough diagnostic process outlined in the "Guidelines for the Diagnosis and Treatment of Cough (2021)" issued by the Asthma Group of the Respiratory Disease Branch of the Chinese Medical Association, still have an unclear etiology, or have no relief after treatment for known causes; (3) Cough Visual Analog Scale (VAS) = 40 mm; (4) Signed informed consent form with the date indicated.
Exclusion criteria
Exclusion criteria: (1) Current smokers or those who have quit smoking for less than 2 years;(2) History of respiratory infection within the 8 weeks prior to the assessment;(3) Presence of liver or kidney diseases affecting drug metabolism;(4) Individuals requiring long-term use of angiotensin-converting enzyme inhibitors (ACEIs);(5) Use of macrolide antibiotics or proton pump inhibitors for cough treatment within 12 weeks prior to the first dose;(6) Presence of hypertension or other cardiovascular diseases;(7) Contraindications or allergies to the study drug;(8) Coexisting mental illness or substance dependence;(9) Pregnant or breastfeeding women;(10) Any other conditions deemed unsuitable for participation in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour cough frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Leicester Cough Questionnaire;cough visual analog scale;Hull airway reflux questionnaire ;Newcastle Laryngeal Hyperresponsiveness Questionnaire;Capsaicin cough sensitivity;Patient Health Questionnaire-9;Generalized Anxiety Disorder-7;cough hypersensitivity assessment test; | — |
Countries
China
Contacts
Public ContactXu Xianghuai
Shanghai Tongji Hospital
Outcome results
None listed