Refractory Chronic Cough
Conditions
Interventions
Low-dose Clexacalim group:The low dose of Clexacalim is 20 mg, administered orally once daily. The course of treatment was 8 weeks.
How-dose Clexacalim group:The high dose of Clexacalim is 20 mg, administered orally twice daily. The course of treatment was 8 weeks.
Control group:Gabapentin was initiated at a dose of 100 mg, administered orally three times daily. The dose was then increased by 100 mg every 3 days until a maintenance dose of 300 mg, three times da
Sponsors
Tongji Hospital Affiliated to Tongji University
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 cough who remain without a clear etiology after comprehensive evaluation according to the chronic cough diagnostic algorithm 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, or whose symptoms show no improvement despite targeted treatment for identified causes; 3. Cough Visual Analog Scale (VAS) score >= 40 mm; 4. Signed and dated informed consent form.
Exclusion criteria
Exclusion criteria: 1. Current smokers or those who have quit smoking for less than 2 years; 2. History of respiratory tract infection within 8 weeks prior to evaluation; 3. Presence of hepatic or renal disease that may affect drug metabolism; 4. Require long-term use of angiotensin-converting enzyme inhibitors (ACEIs); 5. Initiation of macrolide antibiotic or proton pump inhibitor therapy for cough within 12 weeks before the first dose; 6. Comorbid hypertension or other cardiovascular diseases; 7. Contraindications or hypersensitivity to the investigational drug; 8. Comorbid psychiatric disorders or substance dependence; 9. Coexisting major respiratory diseases such as asthma, COPD, tuberculosis, or lung cancer; 10. Severe underlying diseases of the heart, liver, kidneys, nervous system, etc., which in the investigator's judgment may compromise safety assessment; 11. Pregnant or lactating women; 12. Patients who have undergone surgery within 6 months; 13. Any other condition deemed by the investigator as unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cough frequency relative to baseline, as assessed by the 24-hour cough recorder.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Leicester Cough Questionnaire;Visual Analogue Scale for Cough;Daytime and Night - time Cough Symptom Score;Hull Airway Reflux Questionnaire;Capsaicin Cough Thresholds C2 and C5;Gastroesophageal Reflux Disease - Questionnaire;Patient Health Questionnaire-9;Generalized Anxiety Disorder 7 - item Scale;Newcastle Laryngeal Hypersensitivity Questionnaire Score;Change from Baseline in Awake Cough Frequency;Change in nocturnal cough frequency from baseline;Proportion of patients achieving a reduction in cough frequency of >=30%, >=50%, and >=70%;Somatic Symptom Disorder - B Criteria Scale(SSD-12);Patient Health Questionnaire-15(PHQ-15); | — |
Countries
China
Contacts
Public ContactXu Xianghuai
Tongji Hospital Affiliated to Tongji University
Outcome results
None listed