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

Sponsor

Shandong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01677403

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiectasis	Drug: Tobramycin Drug: Saline	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nebulised Tobramycin Nebulised Tobramycin	Drug: Tobramycin Nebulised 80mg twice daily
Placebo Comparator: Nebulised 0.9% Saline Nebulised 0.9% Saline	Drug: Saline Nebulised 5mls 0.9% Saline twice daily

Arm

Intervention/Treatment

Active Comparator: Nebulised Tobramycin

Nebulised Tobramycin

Drug: Tobramycin

Nebulised 80mg twice daily

Placebo Comparator: Nebulised 0.9% Saline

Nebulised 0.9% Saline

Drug: Saline

Nebulised 5mls 0.9% Saline twice daily

Outcome Measures

Primary Outcome Measures

To evaluate change in density of Pseudomonas aeruginosa in sputum [days 1,7,14]

Secondary Outcome Measures

To evaluate chang in the amount of sputum [days 1,7,14]
To evaluate chang in patients' cough severity [days 1,7,14]
To evaluate change in pulmonary function [days 1,7,14]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female study subjects ≥18 years of age and ≤80 years of age
Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis
Confirmation of infection with P. aeruginosa at screening
Are sensitive to Tobramycin
Acute exacerbation of bronchiectasis -

Exclusion Criteria:

Bronchiectasis due to special causes.
Smokers.
Are associated with bronchial asthma.
Have any serious or active medical or psychiatric illness.
Are not tolerant to nebulised tobramycin
FEV1.0 reduces ≥ 15% after inhaling tobramycin. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong University	Jinan	Shandong	China	250100

Sponsors and Collaborators

Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qi Qian, Principal Investigator, Shandong University

ClinicalTrials.gov Identifier:

NCT01677403

Other Study ID Numbers:

qlhqiqian
QL

First Posted:

Sep 3, 2012

Last Update Posted:

Dec 5, 2012

Last Verified:

Dec 1, 2012

Keywords provided by Qi Qian, Principal Investigator, Shandong University

Bronchiectasis

Tobramycin

nebulised

Additional relevant MeSH terms:

Bronchiectasis

Tobramycin

Study Results

No Results Posted as of Dec 5, 2012