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A central-randomized, double-blind, parallel-controlled, multicenter clinical trial using placebo to verify the efficacy and safety of inhaled ambroxol hydrochloride solution for improving sticky sputum symptoms in lower respiratory tract infectious diseases

A central-randomized, double-blind, parallel-controlled, multicenter clinical trial using placebo to verify the efficacy and safety of inhaled ambroxol hydrochloride solution for improving sticky sputum symptoms in lower respiratory tract infectious diseases

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072466
Enrollment
Unknown
Registered
2023-06-14
Start date
2013-09-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Infectious diseases of the lower respiratory tract

Interventions

Experimental group:=6 months ~ <2 years old: 1ml of ambroxol hydrochloride solution for inhalation, inhalation, 2 times a day
=2 years old ~ =12 years old: 2ml of ambroxol hydrochloride solution for inhalation, inhalation, 2 times a day
Control group:=6 months ~ <2 years old: 1ml of ambroxol hydrochloride solution matrix for inhalation, inhalation, 2 times a day
= 2 years old ~ = 12 years old: 2ml of ambroxol hydrochloride solution matrix for inhalation, inhalation, 2 times a day. Medication time: 2 doses every 24 hours, with no less than 6 hours between 2 do

Sponsors

Beijing Children's Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for lower respiratory tract infections (such as acute bronchitis, pneumonia, etc.); 2. Must have sticky sputum and difficulty coughing up sputum (cough =2 points) symptoms; 3. Hospitalized children; 4. Age 6 months to 12 years old, gender is not limited; 5. Voluntary signing of consent form by the legal guardian of the admitted child (at the same time> 10aged children need to voluntarily sign the informed consent form)

Exclusion criteria

Exclusion criteria: 1. Those with allergies (those who are allergic to more than two types of substances) or those who are known to be allergic to the ingredients contained in the experimental drugs; 2. Children with upper respiratory tract infection; 3. Children with lower respiratory tract infection with wheezing symptoms (need bronchodilator therapy); 4. Children with severe pneumonia, bronchiolitis, bronchial asthma, bronchiectasis and pulmonary fibrosis; 5. Those with respiratory depression or tissue hypoxia; 6. Patients with serious cardiovascular and cerebrovascular, liver, kidney and hematopoietic system primary diseases; 7. Patients with drug dependence, or patients with mental disorders; 8. Those who have participated in or are participating in other clinical trials within 3 months

Design outcomes

Primary

MeasureTime frame
cough;

Secondary

MeasureTime frame
Phlegm in the larynx;Pulmonary rales;

Countries

China

Contacts

Public ContactKunling Shen

Beijing Children's Hospital Affiliated to Capital Medical University

kunlingshen1717@163.com+86 139 1072 7586

Outcome results

None listed

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