Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa Clinical Trial
Official title:
Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection
The use of inhaled medications for the treatment of pulmonary diseases allows for the
delivery of a high concentration of a drug at the site of disease with reduced systemic
absorption and risk of systemic adverse effects. Inhaled Tobramycin has been successfully
used in the maintenance treatment of CF patients with chronic colonization with PA
(Pseudomonas aeruginosa). In the CF population TOBI has been proven to improve lung
functions, decrease the density of the PA in the sputum, decrease hospitalizations, and
reduce the risk of mortality.
Non CF Bronchiectasis share many features in common with CF, including frequent colonization
with PA that leads to deterioration in lung function and increased morbidity. A recent
Cochrane review concluded that there is a small benefit for the use of prolonged antibiotics
in the treatment of bronchiectasis, however further randomized controlled trials with
adequate power and standardized end points are required.
There have been reports in the literature describing the efficacy of inhaled tobramycin the
treatment of patients with non CF bronchiectasis with eradication of PA, and significant
improvement in respiratory symptoms. There were however patients who discontinued treatment
due to adverse events most commonly cough wheezing and dyspnea. (Scheinberg and Shore, Chest
2005).
TOBI Podhaler is a dry powder inhaler that was recently launched, and is much easier and
faster to use compared to nebulised Tobramycin. To the best of our knowledge Tobramycin dry
powder formulation has not yet been trialed in patients with non CF bronchiectasis.
The purpose of this trial is to assess the efficacy and tolerability of TOBI Podhaler in
patients with non CF bronchiectasis, and to gather more data on the benefit of continuous
antibiotic therapy in patients with non CF bronchectais.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment