Lower respiratory tract infection
Conditions
Interventions
therapy group:Children 12 years old and above: Inhalation by atomization, 3ml each time, inhalation 2 times a day
Children 2~<12 years old: Nebulized inhalation, 2ml each time, 2 times a day
Children from 6 months to <2 years old: Inhalation by nebulization, 1ml each time, 2 times a day.
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
0.5 Years to 18 Years
Inclusion criteria
Inclusion criteria: (1) Children diagnosed with acute lower respiratory tract infections, such as acute bronchitis (including asthmatic bronchitis), bronchiolitis, acute pneumonia, etc.; (2) Accompanied by symptoms of coughing, sticky sputum, and difficulty in expectoration, cough >= 2 points in review of the past 24 hours; (3) Hospitalized children aged >= 6 months; (4) The course of this disease is less than 7 days; (5) Voluntary participation in this study, the legal guardian signs an informed consent form, and the process of obtaining informed consent complies with GCP regulations (When children are able to make a decision to consent to participate in clinical trials, they should also obtain their own consent ; When the children subjects reach the condition of signing the informed consent, they need to sign the informed consent before they can continue to implement it.)
Exclusion criteria
Exclusion criteria: (1) Children with upper respiratory tract infections; (2) Children with severe pneumonia, bronchial asthma, and interstitial lung disease; (3) Children with diseases accompanied by a large number of secretions in the respiratory tract, such as primary ciliary dyskinesia, bronchiectasis; (4) Children with heart, brain, liver, kidney, blood, immune, endocrine system and skin organs, or with congenital respiratory diseases or malnutrition; (5) Children with peptic ulcer; (6) Children with liver function test ALT or AST > 1.5 times the upper limit of normal, or TBil > upper limit of normal, or children with renal function test Scr > upper limit of normal; (7) People with allergies or known allergies to the ingredients contained in the drugs used in this study; (8) Children who need to use systemic antihistamines during the study period; (9) Those who are participating in other clinical trials or have participated in other clinical trials within the past 3 months; (10) Suspected or true history of drug abuse, or other diseases or conditions that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator; (11) Children with poor compliance and unable to complete this clinical study; The investigator believes that it is not suitable to participate in this clinical tiral.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough improvement rate;Clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Decreased cough score;The improvement rate and decrease of phlegm score in the throat;Improvement rate and decrease of lung auscultation score; | — |
Countries
China
Contacts
Public ContactXu Baoping
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed