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

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

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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

To evaluate change in density of Pseudomonas aeruginosa in sputum

Secondary Outcome

 To evaluate chang in the amount of sputum

Condition

Bronchiectasis

Intervention

Tobramycin

Study Arms / Comparison Groups

 Nebulised Tobramycin

Description:  Nebulised Tobramycin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

120

Start Date

August 2012

Completion Date

December 2014

Primary Completion Date

December 2014

Eligibility Criteria

        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. -
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, , [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT01677403

Organization ID

qlhqiqian

Secondary IDs

QL

Responsible Party

Principal Investigator

Study Sponsor

Shandong University

Study Sponsor

, , 

Verification Date

December 2012