Respiratory tract infection
Conditions
Interventions
therapy group :Ambroxol hydrochloride solution is inhaled and is atomized and inhaled through an inhalation device.Each time 3ml, one Inhalation twice a day, atomization time interval at least 6 hours
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged from 18 to 80 years (including boundary age), male or female; 2. Subjects diagnosed with acute and chronic respiratory diseases, such as acute bronchitis (including acute attack of chronic bronchitis), chronic bronchitis, pneumonia, stable stage of chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, bronchiectasis, etc; 3. Subjects with sticky sputum symptom (sputum character >= 2 points) and expectoration difficulty symptom (expectoration difficulty >= 2 points); Adult post marketing clinical study of ambroxol hydrochloride solution for inhalation version No.: V01, version date: September 1st, 2020; 4. Subjects who can tolerate aerosol inhalation therapy; 5. The volunteers in this study signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects only diagnosed with upper respiratory tract diseases; 2. Subjects with severe pneumonia, bronchial asthma, interstitial lung disease, bronchiectasis and massive hemoptysis; 3. Subjects with impaired bronchial motor function and more secretions (such as the rare malignant ciliary syndrome) may cause airway obstruction by using research drugs; 4. Subjects with serious diseases of heart, brain, liver, kidney, blood, immunity, endocrine, skin, spirit, etc; 5. Subjects with ALT or ast > 2 times of the upper limit of normal value in liver function test, or subjects with SCR > 1.5 times of the upper limit of normal value in renal function test; 6. Subjects who had used expectorant drugs within 48 hours before enrollment, such as N-acetylcysteine, standard Myrtle oil, carboxymethyl Stan, eucalyptus, Caragana, pinene enteric coated capsules, ambroxol hydrochloride in other dosage forms, traditional Chinese medicine and proprietary Chinese medicine for respiratory diseases, etc; 7. Subjects who can not comply with the use of research drugs or the combination of drugs specified in the research protocol; 8. Subjects who are unable to expectorate, such as long-term bedridden, advanced lung cancer, requiring mechanical ventilation, etc; 9. Subjects who are known to be allergic to two or more kinds of allergens, or known to be allergic to the ingredients contained in the research drug; 10. Pregnant, lactating or planned pregnant subjects (including men and women); 11. Subjects who are participating in other clinical studies or have participated in other clinical studies in recent 3 months; 12. Subjects with suspected or true history of drug abuse, or other diseases or conditions that reduce or complicate the possibility of enrollment according to the judgment of the researcher; 13. Subjects considered unsuitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in sputum character scores;Difficulty of expectoration, volume of sputum, cough score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difficulty of expectoration, volume of sputum, cough score; | — |
Countries
China
Contacts
Public ContactJinping Zheng
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed