search
Back to results

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

Primary Purpose

Bronchiectasis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tobramycin
Saline
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, Tobramycin, nebulised

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nebulised Tobramycin

Nebulised 0.9% Saline

Arm Description

Nebulised Tobramycin

Nebulised 0.9% Saline

Outcomes

Primary Outcome Measures

To evaluate change in density of Pseudomonas aeruginosa in sputum

Secondary Outcome Measures

To evaluate chang in the amount of sputum
To evaluate chang in patients' cough severity
To evaluate change in pulmonary function

Full Information

First Posted
August 26, 2012
Last Updated
December 4, 2012
Sponsor
Shandong University
search

1. Study Identification

Unique Protocol Identification Number
NCT01677403
Brief Title
A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, Tobramycin, nebulised

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nebulised Tobramycin
Arm Type
Active Comparator
Arm Description
Nebulised Tobramycin
Arm Title
Nebulised 0.9% Saline
Arm Type
Placebo Comparator
Arm Description
Nebulised 0.9% Saline
Intervention Type
Drug
Intervention Name(s)
Tobramycin
Intervention Description
Nebulised 80mg twice daily
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Nebulised 5mls 0.9% Saline twice daily
Primary Outcome Measure Information:
Title
To evaluate change in density of Pseudomonas aeruginosa in sputum
Time Frame
days 1,7,14
Secondary Outcome Measure Information:
Title
To evaluate chang in the amount of sputum
Time Frame
days 1,7,14
Title
To evaluate chang in patients' cough severity
Time Frame
days 1,7,14
Title
To evaluate change in pulmonary function
Time Frame
days 1,7,14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi
Email
xiaokangqlh@163.com
Facility Information:
Facility Name
Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250100
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs