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

December 4, 2012 updated by: Qi Qian, Shandong University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250100
        • Recruiting
        • Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Nebulised Tobramycin
Drug: Tobramycin
Nebulised 80mg twice daily
PLACEBO_COMPARATOR: Nebulised 0.9% Saline
Drug: Saline
Nebulised 5mls 0.9% Saline twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate change in density of Pseudomonas aeruginosa in sputum
Time Frame: days 1,7,14
days 1,7,14

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate chang in the amount of sputum
Time Frame: days 1,7,14
days 1,7,14
To evaluate chang in patients' cough severity
Time Frame: days 1,7,14
days 1,7,14
To evaluate change in pulmonary function
Time Frame: days 1,7,14
days 1,7,14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

August 26, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (ESTIMATE)

September 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qlhqiqian
  • QL (REGISTRY: QQian)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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