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Clinical study on individualized precision treatment strategy of refractory cough neuromodulator

Clinical study on individualized precision treatment strategy of refractory cough neuromodulator

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000035572
Enrollment
Unknown
Registered
2020-08-14
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory cough/Refractory gastroesophageal reflux cough

Interventions

Subtopic 1- HARQ Prediction Group:None
Subtopic 1-control group:None
Subtopic 2-Esophageal Pressure Measurement Parameter Prediction Group:None
Subtopic 2-control group:None

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subtopic 1: 1. Aged 18 to 70 years; 2. Cough is the main symptom, the course of cough is more than 2 months, and there is no obvious abnormality in chest imaging; 3. According to the Asthma Group of the Chinese Society of Respiratory Diseases The promulgated "Guidelines for the Diagnosis and Treatment of Cough (2015)" Chronic Cough Diagnosis Procedures. After a comprehensive examination, the cause cannot be clarified, or for patients with refractory cough whose known cause has not been relieved after treatment; 4. The total score of the patient's cough symptom score >=3 points; 5. The subject has a clear understanding of the purpose of the study, is willing and able to complete the study in compliance with the requirements, and signs an informed consent form. Subtopic 2: 1. Aged 18 to 70 years men and women; 2. Cough is the main symptom, the course of cough is more than 2 months and the chest imaging examination shows no obvious abnormalities; 3. According to the Asthma Group of the Chinese Society of Respiratory Diseases The issued "Guidelines for the Diagnosis and Treatment of Cough (2015)" and the diagnostic criteria in our department combined with the Lyon Consensus of Gastroesophageal Reflux Disease,patients who meet the following could be suspected refractory gastroesophageal reflux cough: (1) Chronic cough, with or without common reflux symptoms such as acid reflux, heartburn, sternum and pain; (2) MII-pH meets one of the following or more: 1) Esophageal acid exposure time> 6%; 2) Total reflux times> 80 times/24h; 3) Symptom-related probability =95%; (3) Standard anti-reflux (omeprazole 20 mg, 2 times/day before meals + mosapride 5 mg, 3 times/day) treatment for 8 weeks without relief of cough; 4. The total score of the patient's cough symptom score >=3; 5. The subject clearly understands the purpose of the study, is willing and able to complete the study in compliance with the requirements, and signs an informed consent form.

Exclusion criteria

Exclusion criteria: Subtopic 1: 1. pregnant or lactating women; 2. smoking or quitting smoking for <=2 years; 3. a history of new respiratory infections within 8 weeks; 4. a history of contraindications or allergies to gabapentin treatment; 5. active liver and kidney disease. Subtopic 2: 1. pregnant or breast-feeding women; 2. smoking or quitting smoking for <=2 years; 3. a history of new respiratory infections within 8 weeks; 4. a history of contraindications or allergies to baclofen treatment; 5. active liver and kidney disease.

Design outcomes

Primary

MeasureTime frame
The success rate of gabapentin in the treatment of patients with refractory cough;The success rate of baclofen in the treatment of refractory gastroesophageal reflux cough;

Secondary

MeasureTime frame
Cough symptom score;VAS;LCQ;HARQ;NLHQ;Capsaicin cough sensitivity;GerdQ;

Countries

China

Contacts

Public ContactZhongmin Qiu

Shanghai Tongji Hospital

qiuzhongmin@tongji.edu.cn+86 13671892140

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026