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

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ClinicalTrials.gov Identifier: NCT01677403
Recruitment Status : Unknown
Verified December 2012 by Qi Qian, Shandong University.
Recruitment status was:  Recruiting
First Posted : September 3, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
Qi Qian, Shandong University

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 Type : Interventional  (Clinical Trial)
Estimated 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 : August 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. To evaluate change in density of Pseudomonas aeruginosa in sputum [ Time Frame: days 1,7,14 ]

Secondary Outcome Measures :
  1. To evaluate chang in the amount of sputum [ Time Frame: days 1,7,14 ]
  2. To evaluate chang in patients' cough severity [ Time Frame: days 1,7,14 ]
  3. To evaluate change in pulmonary function [ Time Frame: days 1,7,14 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677403


Contacts
Contact: Qi xiaokangqlh@163.com

Locations
China, Shandong
Shandong University Recruiting
Jinan, Shandong, China, 250100
Sponsors and Collaborators
Shandong University

Responsible Party: Qi Qian, Principal Investigator, Shandong University
ClinicalTrials.gov Identifier: NCT01677403     History of Changes
Other Study ID Numbers: qlhqiqian
QL ( Registry Identifier: QQian )
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

Keywords provided by Qi Qian, Shandong University:
Bronchiectasis
Tobramycin
nebulised

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents