None listed
Conditions
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 19 and = 75 2. In visit 1, Chronic cough patients who lasted for more than 8 weeks 3. In visit 1, daily cough severity rating scale (0-10 NRS) score = 3 and Leicester Cough Questionnaire (LCQ) score <15 4. In visit 1, Those who have been diagnosed with gastroesophageal reflux disease based on the time of screening and have experienced typical symptoms (heartburn or acid reflux) of gastric acid reflux within 7 days prior to the time of screening 5. A person who voluntarily agreed in writing to participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1. Those who showed cough-related abnormalities in chest X-ray examination at the time of screening (however, whether it is related to cough or not depends on the tester' 2. Those who have less than 70% of FEV1/FVC according to the lung function test results at the time of screening 3. Those who exceeded 25 ppb as a result of the inspection of exhaled nitrogen oxide at the time of screening 4. Those who have symptoms and signs of cough-related diseases that require treatment at the time of screening (symptoms such as asthma, eosinophilia, upper respiratory tract cough syndrome, lung disease, etc; symptoms such as shortness of breath, fever, sneezing, nasal congestion, suppurative sputum, etc.) 5. Those who have a positive history (PC20 is less than 16 mg/ml) in the results of the previous methacholine bronchial inspection 6. A person who has a history of eosinophilic division exceeding 3% according to the results of the previous induced sputum test 7. Those who have a history of treating proton pump inhibitors (PPI) or other gastric acid secretion inhibitors (H2 receptor antagonists, potassium competitive gastric acid secretion inhibitors (P-CAB), antigastrin agents, etc.) within 8 weeks of screening; 8. Those who have warning symptoms (low-bottom pain, severe dysphagia, bleeding, weight loss, anemia, bloody stool) that can estimate a malignant disease in the gastrointestinal tract 9. A person who has confirmed the following surgical history or history at the time of screening; (1) Respiratory infection within 4 weeks prior to screening (2) Antirefusion surgery or antirefusion endoscopy (3) Respiratory digestive malignancy or barrette esophagus (4) Lung or esophageal cancer (5) Malignant tumors within 5 years other than paragraph (4) (However, if more than 5 years have elapsed without recurrence after complete remission, participation is possible) (6) A history of organic neuro/mental illness (such as major depressive or anxiety disorders), alcoholism, substance abuse and drug dependence (except nicotine and caffeine) 10. Those who have diseases in the liver, kidney, nervous system, respiratory system, endocrine system, blood, tumor, cardiovascular system, and urology that can affect the interpretation of the results of clinical trials at the time of screening 11. A person who has administered the following medication that may affect the interpretation of the results of a clinical trial prior to the time of screening: (1) Angiotensin Conversion Enzyme Inhibitors (ACEi) administered within 8 weeks following medication administered within 2 weeks (2) Atazanavir, Nelphinavir, Lilpibirin (3) gastric mucosal protection (4) Gastrointestinal motility promoters: methoclopramide, itopride, etc (5) digestive system true economy (6) Anticholinergic and cholineergic (7) Opium preparations such as codeine, or composites containing codeine components, etc (8) Other pesticides (theobromine, levodropurizine, etc.) For the following drugs, exceptions are allowed if they are being administered as maintenance therapy three months ago based on the screening time for the purpose of treating underlying diseases. (9) gabapentin, pregabalin, amitriptyline, etc (10) Anti-leukotrienes (11) Oral or nasal antihistamines; (12) Methylxanthine (13) Inhalation beta-agonist (14) Corticosteroids for whole body, inhalation, and intracranial adrenal cortex; however, skin application is permitted regardless of maintenance therapy However, among the drugs, drugs for the p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LCQ total score changes | — |
Secondary
| Measure | Time frame |
|---|---|
| LCQ total score changes;NRS score changes, daily Cough Severity NRS Cumulative Score (2 Weeks from baseline);change in RDQ average score;Correlation coefficient between the RDQ average score of the baseline and the change in total LCQ points at 8 weeks relative to the baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactWoo Jung Song
Asan Medical Center
Outcome results
None listed