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

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Bronchiectasis

Treatments: Drug: Saline; Drug: Tobramycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01677403

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QL (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Nebulised Tobramycin

Active Comparator group

Description:

Nebulised Tobramycin

Treatment:

Drug: Tobramycin

Nebulised 0.9% Saline

Placebo Comparator group

Description:

Nebulised 0.9% Saline

Treatment:

Drug: Saline