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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Shandong University
Sponsor:
Information provided by (Responsible Party):
Qi Qian, Shandong University
ClinicalTrials.gov Identifier:
NCT01677403
First received: August 26, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Shandong University:

Primary Outcome Measures:
  • To evaluate change in density of Pseudomonas aeruginosa in sputum [ Time Frame: days 1,7,14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate chang in the amount of sputum [ Time Frame: days 1,7,14 ] [ Designated as safety issue: No ]
  • To evaluate chang in patients' cough severity [ Time Frame: days 1,7,14 ] [ Designated as safety issue: No ]
  • To evaluate change in pulmonary function [ Time Frame: days 1,7,14 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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. -
  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 ClinicalTrials.gov identifier: NCT01677403

Contacts
Contact: Qi xiaokangqlh@163.com

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

No publications provided

Responsible Party: Qi Qian, Principal Investigator, Shandong University
ClinicalTrials.gov Identifier: NCT01677403     History of Changes
Other Study ID Numbers: qlhqiqian, QL
Study First Received: August 26, 2012
Last Updated: December 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shandong University:
Bronchiectasis
Tobramycin
nebulised

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

ClinicalTrials.gov processed this record on July 28, 2014