Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT01677403
Status:
UNKNOWN
Last Update Posted:
2012-12-05
First Post:
2012-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
Sponsor:
Shandong University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2012-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| QL | REGISTRY | QQian | View |