Gastroesophageal reflux-related cough
Conditions
Interventions
Group A:Esomeprazole (20mg, BID)
Group B:Esomeprazole (20mg, BID) and Cinitapride (1mg, TID)
Group C:Esomeprazole (20mg, BID) and Domperidone (10mg, TID)
Group D:Esomeprazole (20mg, BID) and Itopride (50mg, TID)
Group E:Vonoprazan (20mg, QD) and Itopride (50mg, TID)
GERD group:Collecting saliva, sputum and bronchoalveolar lavage fluid for detecting pepsin
Chronic cough group:Collecting saliva, sputum and bronchoalveolar lavage fluid for detecting pepsin
Healthy control group:Collecting saliva, sputum and bronchoalveolar lavage fluid for detecting pepsin
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. GERC: (1) Cough as the only or main symptom and lasting for more than 8 weeks. (2) 24-hour esophageal pH-impedance monitoring: DeMeester score=12.7 and (or) Symptom Association Probability (SAP)=80%, and (or) the increased number of reflux episodes. (3) If the ambulatory reflux monitoring is not available: a. presenting with obvious cough associated with eating; b. with typical GERD symptoms (heartburn and acid regurgitation, etc), or at least one questionnaire score exceeding the cut-off value(GerdQ=8, HARQ=13 or RSI=13). (4) Excluding the common causes of chronic cough, such as cough variant asthma, upper airway cough syndrome, eosinophilic bronchitis, etc. 2. GERD: (1) With typical retrosternal burning (heartburn), regurgitation or with chest distress, chest pain, water brash, epigastric pain, bloating, belching, etc. (2) 24-hour esophageal pH-impedance monitoring: DeMeester score=12.7 and (or) SAP=80%, or oesophageal acid exposure time (AET)>4.2%, or reflux episodes=80. 3. Chronic cough patients (except for GERC): (1) Cough lasting for more than 8 weeks. (2) Without abnormality of the ambulatory reflux monitoring. 4. Healthy subjects: without cough and GERD symptoms, as well as GerdQ<8, HARQ<13 and (or) RSI<13.
Exclusion criteria
Exclusion criteria: 1. With more than a 10-pack-year history of smoking. 2. Having respiratory infection in the past 4 weeks. 3. Continuous use of angiotensin converting enzyme inhibitors (ACEI) in the past 4 weeks or for a long term. 4. Having a history of esophageal stenosis, gastrointestinal ulcer, hiatal hernia, esophageal motility disorders, esophageal and gastric tumors, upper gastrointestinal surgery. 5. Complicating with serious systemic diseases, such as heart, brain, liver and kidney diseases. 6. Patients with severe mental disorders that cannot cooperate to finish treatment and follow-up. 7. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate;Pepsin concentration;Positive rate of pepsin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cough visual analogue scale (VAS);Cough evaluation test (CET);Leicester cough questionnaire (LCQ);Cough symptom score (CSS);Gastroesophageal reflux disease questionnaire (GerdQ);Hull Airway Reflux Questionnaire (HARQ);Reflux symptom index (RSI);Lowest concentration of capsaicin inducing at least two coughs (C2);Lowest concentration of capsaicin inducing at least five coughs (C5);Urge to cough (UTC); | — |
Countries
China
Contacts
Public ContactRuchong Chen
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed