This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Qi Qian, Shandong University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Qi Qian, Shandong University Identifier:
First received: August 26, 2012
Last updated: December 4, 2012
Last verified: December 2012
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 Intervention Phase
Bronchiectasis Drug: Tobramycin Drug: Saline Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Qi Qian, Shandong University:

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

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

Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01677403

Contact: Qi

China, Shandong
Shandong University Recruiting
Jinan, Shandong, China, 250100
Sponsors and Collaborators
Shandong University
  More Information

Responsible Party: Qi Qian, Principal Investigator, Shandong University Identifier: NCT01677403     History of Changes
Other Study ID Numbers: qlhqiqian
QL ( Registry Identifier: QQian )
Study First Received: August 26, 2012
Last Updated: December 4, 2012

Keywords provided by Qi Qian, Shandong University:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 21, 2017