This product is suitable for expectorant treatment of acute and chronic bronchial diseases and acute and chronic lung diseases accompanied by sputum secretion.
Conditions
Interventions
experimental group:Ambroxol hydrochloride solution for inhalation, 22.5mg / 3ml each time, twice a day
control group:Placebo, 3ml each time, 2 times a day.
Sponsors
chongqing general hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for lower respiratory tract infection (acute exacerbation of chronic bronchitis, pneumonia, acute exacerbation of chronic obstructive pulmonary disease); 2. Patients with lower respiratory tract infection who have symptoms of sticky sputum (sputum trait score >= 3 points) and difficulty sputum production (difficulty in sputum production> 60 mm); 3. Inpatients; 4. Aged 18-75 years (including 18 years old and 75 years old), regardless of gender; 5. Sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to the ingredients contained in the test drug and the equipment used; 2. Patients with bronchial asthma, sinusitis, cardiac insufficiency, severe pulmonary infection (who needs ICU comprehensive treatment), active pulmonary tuberculosis, tuberculous pleurisy, and severe respiratory failure requiring ventilator (invasive or non-invasive) adjuvant therapy; 3. Patients with weak sputum (such as long-term bed rest, advanced lung cancer, etc.); 4. Those who cannot cooperate with atomization treatment or need physical sputum discharge; 5. Patients who used cough and expectorant Chinese medicine and western medicine within 24 hours (including 24 hours) before entering the group (Except for patients with acute exacerbation of COPD who are in maintenance treatment); 6. Patients using systemic hormones within 24 hours (including 24 hours) before enrollment (except for patients with acute exacerbation of COPD who are on maintenance therapy); Patients with white blood cells > 18 x 10^9 / L before enrollment; 7. Patients with white blood cells > 18 x 10^9 / L before enrollment; 8. Patients with severe heart, cerebrovascular, liver (ALT or AST > 3 times the upper limit of normal value), kidney (Cr> 1.5 times the upper limit of normal value), immunodeficiency and primary and secondary diseases of the hematopoietic system (platelet count < 30 x 10^9 / L); 9. Patients with alcoholism and drug dependence, or patients with mental disorders; 10. Women who are pregnant or breastfeeding or plan to become pregnant (including men and women); 11. People who have participated in or are participating in other clinical trials within 3 months; 12. The investigator thinks it is not suitable for enrolling patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum trait score-time area under the curve (AUC); | — |
Secondary
| Measure | Time frame |
|---|---|
| Sputum difficulty;Cough severity;Sputum volume (including sputum volume and mass); | — |
Countries
China
Contacts
Public ContactLiu Rongge
The Second Affiliated Hosptial of Xingtai Medical College
Outcome results
None listed