Lower respiratory infectious diseases [such as acute attack of chronic bronchitis, acute exacerbation of chronic obstructive pulmonary disease, bronchiectasis (mild columnar bronchiectasis without hemoptysis), pneumonia, acute bronchitis, etc
Conditions
Interventions
Test group:Inhalation of Bromhexine Hydrochloride Solution
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who meet the clinical diagnostic criteria for lower respiratory infectious diseases [such as acute attack of chronic bronchitis, acute exacerbation of chronic obstructive pulmonary disease, bronchiectasis (mild columnar bronchiectasis without hemoptysis), pneumonia, acute bronchitis, etc; 2. Must have symptoms of mucus (sputum trait score >= 2 points) and clinical symptoms such as difficulty in coughing up phlegm (difficulty score >= 2 points); 3. Age range from 18 to 80 years old (including 18 and 80 years old), gender not limited; 4. The subjects fully understand and voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Individuals who are known to be allergic to the ingredients and excipients of the investigational drug; 2. Patients who are unable to cough up phlegm (such as long-term bed rest, advanced lung cancer, etc.); 3. Patients with simple bronchial asthma; 4. Patients with concomitant peptic ulcers, bronchiectasis accompanied by hemoptysis, sinusitis, severe pulmonary hypertension (NYHA heart function = grade III), severe pneumonia (requiring ICU comprehensive treatment), and severe respiratory failure requiring assisted ventilation (invasive or non-invasive); 5. Those who cannot cooperate with nebulization therapy or require physical sputum expulsion; 6. Within 2 days before the first administration or during the trial period, it is necessary to use other traditional Chinese and Western medicines that affect the efficacy evaluation, including expectorants, cough suppressants, leukotriene receptor antagonists, antihistamines, etc., other than the investigational drug; 7. Past or current combined history or impact of any of the following major diseases: 1) History of cerebrovascular accidents within the past 6 months, such as ischemic stroke and hemorrhagic stroke; 2) Have a history of unstable angina, myocardial infarction, and acute heart failure within the past 6 months; 3) Sick sinus syndrome, grade II-III atrioventricular block, atrial flutter, atrial fibrillation, and other malignant or potentially malignant arrhythmias; 4) Large artery aneurysm or dissecting artery aneurysm, having undergone major cardiac surgery or undergoing cardiovascular intervention treatment within 6 months; 5) Patients with severe liver disease or liver dysfunction (such as cirrhosis, chronic active hepatitis, etc.); 6) Severe kidney disease patients [such as patients with chronic renal insufficiency (stage II or above), patients with renal artery stenosis, etc.]; 7) History of malignant tumors (excluding any in situ cancer and pulmonary malignant nodules that have been removed and have not recurred for 5 years, as well as stable skin basal cell or squamous cell carcinoma); 8) Individuals with immunodeficiency diseases or taking immunosuppressive agents; 9) Individuals with severe primary hematopoietic system diseases or neutropenia. 8. Before enrollment, any laboratory test indicators met the following criteria: 1) alanine aminotransferase (ALT) and aspartate aminotransferase (AST)>2.0 times the upper limit of normal value (ULN) (refer to the range of normal values in the laboratory test of the research center); 2) Serum creatinine (Cr)>upper limit of normal value (ULN) (refer to the range of normal values detected in the laboratory of the research center). 9. Other general situations that are not suitable for participation in the study: 1) Screening for individuals who have participated in and received drug/medical device interventions within the previous three months, or are currently participating in any other clinical trials; 2) Have a history of drug use, alcohol or substance abuse; 3) Patients with severe neurological and psychiatric disorders who cannot fully understand and cooperate; 4) Pregnant women and male patients of childbearing age who are pregnant, breastfeeding, planning to conceive, or have not taken reliable contraceptive measures, and are unwilling to use contraceptive methods during the trial period and within 30 days after the last medication. Reliable contraceptive measures include: transdermal patches, intrauterine devices/systems (I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in sputum trait scores relative to baseline after completion of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difficulty Score for Coughing Phlegm;sputum volume score;cough severity score;The examination results of vital signs, physical examination, blood routine, urine routine, blood bi; | — |
Countries
China
Contacts
Public ContactRongchang Chen
Shenzhen People's Hospital
Outcome results
None listed