Clinical trial NCT01677403: A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Tobramycin
nebulised
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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. -

Primary outcomes:
measure: To evaluate change in density of Pseudomonas aeruginosa in sputum
timeFrame: days 1,7,14
Secondary outcomes:
measure: To evaluate chang in the amount of sputum
timeFrame: days 1,7,14
measure: To evaluate chang in patients' cough severity
timeFrame: days 1,7,14
measure: To evaluate change in pulmonary function
timeFrame: days 1,7,14
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong University
state: Shandong
Study officials:
References: