?????? ?????? lower respiratory tract infection
Conditions
Interventions
1:Each 3ml ambroxol hydrochloride, Sodium Chloride Injection 3ml 0.9% diluted aerosol inhalation, 2 times a day.
2:Each 3ml placebo,Sodium Chloride Injection 3ml 0.9% diluted aerosol inhalation, 2 times a day.
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnostic criteria for lower respiratory tract infections (e.g., acute exacerbation of chronic bronchitis, pneumonia, acute exacerbation of chronic obstructive pulmonary disease, and column bronchial dilation and without hemoptysis); 2. The patients must have the symptoms of phlegm (sputum score more than 2 points), expectoration difficulty (expectoration difficulty score more than 2 points) and other clinical symptoms; 3. Inpatient; 4. Aged 18 to 75 years male and female; 5. The subjects fully understood and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known to the trial use of drugs containing ingredients and medicinal accessories allergic person; 2. Patients with upper respiratory tract infection; 3. Bronchial asthma, cystic and cystic columnar bronchiectasis or bronchiectasis with hemoptysis and pulmonary interstitial fibrosis, sinusitis, severe pulmonary hypertension and severe pulmonary infection (ICU comprehensive treatment), active pulmonary tuberculosis, tuberculous pleurisy, severe respiratory failure requiring ventilator (invasive or noninvasive) adjuvant therapy for patients; 4. Can't cooperate with atomization treatment or physical sputum elimination; 5. For the first time before drug use within 1 days (-24h) disease phlegm symptoms of traditional Chinese medicine and Western medicine during the test or take drugs other than to improve the study on the removal of lower respiratory tract infection, such as expectorant and antitussive drugs; 6. Previous or current merger of any of the following major disease history or impact study assessment: The patients with cerebrovascular accident history in the past 3 months, such as ischemic stroke and hemorrhagic stroke; The history of unstable angina, myocardial infarction and heart failure in the past 3 months; Unable to expectorate (such as long-term bedridden, patients with advanced lung cancer etc.); The patients with Sick sinus syndrome, II ~ III degree atrioventricular block and atrial flutter and atrial fibrillation and other malignant or potentially malignant arrhythmia; The patients with Aneurysm or aortic dissection, percutaneous transluminal coronary angioplasty or heart surgery; The patients with severe liver disease or liver dysfunction (such as cirrhosis, chronic active hepatitis, etc.); Severe kidney disease patients (such as chronic renal insufficiency, renal artery stenosis, etc.); A history of malignancy ( except for who was diagnosed as a malignant tumor, and is now in stable condition and has received appropriate treatment or resection of non metastatic cutaneous basal cell or squamous cell carcinoma, in situ cervical cancer.); Primary disease of the hematopoietic system, or the absence of a granulocyte; 7. Before entering the group, there is any laboratory test index to meet the following standards: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) >1.5 times the upper limit of normal value (ULN) (Reference Research Center laboratory to examine the range of normal values); Serum creatinine (Cr) >1.5 times the upper limit of normal values (ULN) (Reference Research Center laboratory to examine the range of normal values); 8. Other general conditions which are not suitable for study: To participate in or participate in any other clinical trial in the first 3 months; A history of drug abuse, alcohol or drug abuse; Patients with severe neurological and psychiatric disorders who can not fully understand and cooperate; Women of childbearing age and male patients who are pregnant, nursing or planning to conceive or fail to take reliable birth control measures are not willing to take birth control methods within 30 days after the trial period and the last medication. Including reliable contraceptive measures: transdermal patches, intrauterine device / system (IUD/IUS), and oral contraceptives, implantation or injection of abstinence and condom use, spouse vasectomy; Unable to comply with the requirements of the research program; Others who are not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum score;Expectoration difficulty score;Cough score;Sputum volume score; | — |
Countries
China
Contacts
Public ContactHe Bei
Peking University Third Hospital
Outcome results
None listed