Skip to content

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

A randomized, double-blind, parallel-controlled, multicenter clinical trial 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
ChiCTR2300072467
Enrollment
Unknown
Registered
2023-06-14
Start date
2013-06-06
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:Ambroxol hydrochloride solution for inhalation is 3 ml/22.5 mg twice daily
Control group:Placebo (ambroxol hydrochloride solution matrix for inhalation), 3 ml twice daily

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Patients with mucus sputum symptoms (sputum trait score =2 points) and difficulty in coughing up sputum (difficulty of coughing up sputum =2 points) with lower respiratory tract infections (such as acute onset of chronic bronchitis, pneumonia, acute exacerbation of chronic obstructive pulmonary disease, etc.); 2. Inpatients; 3. Age 18-79 years old, gender is not limited; 4. Voluntarily sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Those who are allergic (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. Patients with upper respiratory tract infection; 3. Patients with bronchial asthma, bronchiectasis and pulmonary interstitial fibrosis; 4. Patients with weakness to cough up sputum (such as long-term bed rest, advanced lung cancer, etc.); 5. Patients with severe primary diseases of cardiovascular and cerebrovascular, liver, kidney and hematopoietic system; 6. Patients with alcoholism and drug dependence, or patients with mental disorders; 7. Pregnant or lactating women or those planning to become pregnant (including men and women); 8. Those who have participated in or are participating in other clinical trials within 3 months

Design outcomes

Primary

MeasureTime frame
Sputum traits;

Secondary

MeasureTime frame
Difficulty in coughing up sputum;Sputum volume;cough;

Countries

China

Contacts

Public ContactZhaolong Cao

Peking University People's Hospital

13601222896@163.com+86 136 0122 2896

Outcome results

None listed

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