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A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients with Acute Exacerbation of Bronchiectasis

A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients with Acute Exacerbation of Bronchiectasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003812
Enrollment
Unknown
Registered
2013-07-28
Start date
2013-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Bronchiectasis

Interventions

Experimental Group:Conventional therapy and nebulised Amikacin
Control Group:Conventional therapy and nebulised 0.9% Saline

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male or female study subjects aged 18 years to 80 years; 2. Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis; 3. Confirmation of infection with Pseudomonas aeruginosa at screening; 4. To be sensitive to amikain; 5. Acute exacerbation of bronchiectasis.

Exclusion criteria

Exclusion criteria: 1. Bronchiectasis due to special causes; 2. Smokers; 3. Are associated with bronchial asthma; 4. Have any serious or active medical or psychiatric illness; 5. Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces >=15% after inhaling amikacin.

Design outcomes

Primary

MeasureTime frame
Pulmonary function tests;Sputum bacterial culture;The rate of sputum bacterial clearance;—

Secondary

MeasureTime frame
Dyspnea score;Cough leve;—

Countries

China

Contacts

Public ContactLi Yu

Shandong University School of Medicine

qlliyu@163.com+86 13791122770

Outcome results

None listed

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