A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
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
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 26, 2012
CompletedFirst Posted
Study publicly available on registry
September 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 5, 2012
December 1, 2012
2.3 years
August 26, 2012
December 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate change in density of Pseudomonas aeruginosa in sputum
days 1,7,14
Secondary Outcomes (3)
To evaluate chang in the amount of sputum
days 1,7,14
To evaluate chang in patients' cough severity
days 1,7,14
To evaluate change in pulmonary function
days 1,7,14
Study Arms (2)
Nebulised Tobramycin
ACTIVE COMPARATORNebulised Tobramycin
Nebulised 0.9% Saline
PLACEBO COMPARATORNebulised 0.9% Saline
Interventions
Eligibility Criteria
You may qualify if:
- Male or female study subjects ≥18 years of age and ≤80 years of age
- Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis
- Confirmation of infection with P. aeruginosa at screening
- Are sensitive to Tobramycin
- Acute exacerbation of bronchiectasis -
You may not qualify if:
- Bronchiectasis due to special causes.
- Smokers.
- Are associated with bronchial asthma.
- Have any serious or active medical or psychiatric illness.
- Are not tolerant to nebulised tobramycin
- FEV1.0 reduces ≥ 15% after inhaling tobramycin. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong University
Jinan, Shandong, 250100, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 26, 2012
First Posted
September 3, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 5, 2012
Record last verified: 2012-12