A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

A Randomized,Controlled Study to Evaluate the Efficacy,Indications,Adverse Reactions and Resistance of Combined Administration of Nebulized Tobramycin Compared With Systemic Administration Alone in Patients With Bronchiectasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01677403
• Other study ID #: qlhqiqian
• Secondary ID: QL
• Status: Recruiting
• Phase: Phase 4
• First received: August 26, 2012
• Last updated: December 4, 2012
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2012
• Source: Shandong University
• Contact: Qi
• Email: xiaokangqlh[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the efficacy,indications,adverse reactions and resistance of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.

Description:

Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients.

This is a study of safety and efficacy of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis. Study subjects will be randomized to receive either study drug or placebo by inhalation via a nebulizer. Each subject will complete 14 days of daily dosing.

Clinical laboratory parameters,clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and efficacy of nebulized tobramycin.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or female study subjects =18 years of age and =80 years of age

2. Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis

3. Confirmation of infection with P. aeruginosa at screening

4. Are sensitive to Tobramycin

5. Acute exacerbation of bronchiectasis -

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. Are not tolerant to nebulised tobramycin

6. FEV1.0 reduces = 15% after inhaling tobramycin. -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• Tobramycin
Nebulised 80mg twice daily
• Saline
Nebulised 5mls 0.9% Saline twice daily

Locations

Country	Name	City	State
China	Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate change in density of Pseudomonas aeruginosa in sputum		days 1,7,14	No
Secondary	To evaluate chang in the amount of sputum		days 1,7,14	No
Secondary	To evaluate chang in patients' cough severity		days 1,7,14	No
Secondary	To evaluate change in pulmonary function		days 1,7,14	No