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

NCT ID: NCT01677403

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Bronchiectasis

Keywords

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Bronchiectasis Tobramycin nebulised

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nebulised Tobramycin

Nebulised Tobramycin

Group Type ACTIVE_COMPARATOR

Tobramycin

Intervention Type DRUG

Nebulised 80mg twice daily

Nebulised 0.9% Saline

Nebulised 0.9% Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Nebulised 5mls 0.9% Saline twice daily

Interventions

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Tobramycin

Nebulised 80mg twice daily

Intervention Type DRUG

Saline

Nebulised 5mls 0.9% Saline twice daily

Intervention Type DRUG

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Qi Qian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qi

Role: CONTACT

Email: [email protected]

Other Identifiers

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QL

Identifier Type: REGISTRY

Identifier Source: secondary_id

qlhqiqian

Identifier Type: -

Identifier Source: org_study_id