Lower respiratory tract infections
Conditions
Interventions
Treatment group:ambroxol hydrochloride solution 3 ml (22.5mg) + 0.9% sodium chloride 3 ml
Control group:0.9% sodium chloride 6ml
Sponsors
First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) men and women aged 18-80 years old. 2) Patients with lower respiratory tract infection (e.g. community-acquired pneumonia, acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of chronic bronchitis, bronchiectasis without hemoptysis) with purulent sputum (sputum property score = 2 points) and expectoration difficulty (expectoration difficulty = 2 points). 3) Patients requiring hospitalization during medication. 4) Patients who were confirmed to meet the target population through clinical symptoms, signs and laboratory tests. 5) The informed consent was signed voluntarily, and the subjects of childbearing age volunteered to take effective contraceptive measures during the trial.
Exclusion criteria
Exclusion criteria: 1) Those who were known to be allergic to the ingredients contained in the study drug. 2) Patients with pulmonary tuberculosis, pneumoconiosis, lung cancer, pulmonary interstitial diseases, asthma, bronchiectasis with hemoptysis, pulmonary interstitial fibrosis and other severe respiratory diseases. 3) Patients with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were greater than 1.5 times the upper limit of the normal value, or serum creatinine (CR) was greater than the upper limit of the normal value (refer to the normal value range of the laboratory examination of the center); Fever accompanied by clear bacterial infection symptoms, and the white blood cell count was greater than 1.5 times the upper limit of the normal value. 4) Patients with alcohol or drug dependence. 5) Patients with a history of epilepsy or mental disorders. 6) Pregnant or lactating women, or those planning pregnancy (including men and women). 7) Those who have participated in or are participating in other clinical trials within 3 months. 8) Patients with difficulty in coughing up sputum due to tracheal stenosis (e.g. the history of respiratory tract tumor, foreign body airway obstruction). 9) Patients complicated with cerebrovascular accident, cachexia, severe consumptive disease, myasthenia, long-term bed rest, etc., resulting in weak or unable sputum expectoration. Patients who cannot expectorate and needed atomization inhalation or tracheotomy for sputum expectoration. 10) Patients who cannot cooperate with inhalation treatment or needed sputum clearance by physiotherapies. 11) Other patients considered unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum property score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cough intensity;Expectoration difficulty;Expectoration volume; | — |
Countries
China
Contacts
Public ContactRongchang Chen
First Affiliated Hospital of Guangzhou Medical University/Shenzhen people's hospital
Outcome results
None listed