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A prospective, multicenter, real-world study of efficacy, safety and compliance of Ambroxol Hydrochloride Spray (Luorunchang ) in the treatment of cough and expectoration induced by acute respiratory infection in children(CHILD CARE STUDY)

A prospective, multicenter, real-world study of efficacy, safety and compliance of Ambroxol Hydrochloride Spray (Luorunchang) in the treatment of cough and expectoration induced by acute respiratory infection in children(CHILD CARE STUDY)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063661
Enrollment
Unknown
Registered
2022-09-14
Start date
2022-09-15
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory infections in children

Interventions

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age 1-12 years old,regardless of gender; 2. Children with acute respiratory tract infection accompanied by thick sputum and difficult sputum excretion (cough symptom score = 2 points during the day or at night); 3. Children who need expectorant treatment; 4. Those who have conditions to observe and record day by day. 5. Children between 1 and 8 years old, the informed consent should be signed by the guardian;Children between 8-12 years old,the informed consent should be signed by both the child and his/her guardian;

Exclusion criteria

Exclusion criteria: 1. Children diagnosed with severe pneumonia; 2. Children with cough duration =2 weeks; 3. Children with previous bronchial asthma and interstitial lung disease; 4. Children with previous other chronic respiratory diseases, such as primary ciliary dyskinesia and bronchiectasis; 5. Patients with previous systemic basic diseases of heart, brain, kidney, blood, immunity, endocrine.Such as congenital heart disease, epilepsy, hemophilia and autoimmune diseases, or children with congenital respiratory diseases and malnutrition; 6. Children with previous peptic ulcer; 7. Participated in other drug trials 3 months prior to inclusion; 8. Those who are known or suspected to be allergic to the ingredients of the drugs used in this study

Design outcomes

Secondary

MeasureTime frame
Disappearance time of main symptoms(wheezy phlegm ? wheezy sound in lung);Changes in quality of life scores before and after treatment;Compliance score;Incidence of adverse events;

Primary

MeasureTime frame
Changes of cough symptom scores before and after treatment;

Countries

China

Contacts

Public ContactXu Baoping
xubaopingbch@163.com13370115002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026