Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa Clinical Trial
— TOBIOfficial 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.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | May 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients with bronchiectasis confirmed by CT 2. Chronic PA colonization with 2 documented sputum cultures positive for PA in the last 24 months. 3. Age >=18 Exclusion Criteria: 1. Patients diagnosed with CF 2. Patients who do not tolerate Tobramycin 3. Pregnant or breastfeeding 4. Patients treated in the last 8 weeks with antibiotic therapy either inhaled or systemic (excluding Azenil PO x 3/week which is allowed) |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Pulmonary Institute, Rabin Medical Center, Beilinson Campus | Petach Tikva |
| Lead Sponsor | Collaborator |
|---|---|
| Rabin Medical Center |
Israel,
Cochrane review: Prolonged antibiotics for purulent bronchiectasis in children and adults (Review), Evans DJ, Bara A, Greenstone M. The Cochrane Collaboration. Published by JohnWiley & Sons, Ltd. 13 January 2011.
Konstan MW, Flume PA, Kappler M, Chiron R, Higgins M, Brockhaus F, Zhang J, Angyalosi G, He E, Geller DE. Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. J Cyst Fibros. 2011 Jan;10(1):54-61. doi: 10.1016/j.jcf.2010.10.003. Epub 2010 Nov 12. — View Citation
Scheinberg P, Shore E. A pilot study of the safety and efficacy of tobramycin solution for inhalation in patients with severe bronchiectasis. Chest. 2005 Apr;127(4):1420-6. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of exacerbations as measured by number of systemic courses of antibiotics either PO or IV | Exacerbation count at 24 weeks, 48 weeks and 52 weeks | 52 weeks total | Yes |
| Secondary | Quality of life and Symptoms Score as measured by SGRQ(Saint George's Respiratory Questionnaire) and CASA-Q-CD (Cough and Sputum Assessment Questionnaire) cough and sputum domains | Control Period Patients will visit the site 3 times every 12 weeks, TOBI Period Patients will visit the clinic at least 4 times a year during this 24 week period, when enrolled to the study during the 48 weeks period of the study | 52 weeks | No |
| Secondary | Pulmonary function tests (FEV1) | Control Period Patients will visit site 3 times every 12 weeks, TOBI Period Patients will visit the clinic at least 4 times a year during this 24 week period, when enrolled to the study during the 48 weeks period of the study | 52 weeks | No |
| Secondary | Sputum microbiology: Change in Pseudomona Aeruginosa density in sputum | Samples will be taken at every visit and changes will be analyzed at the end of the study, when enrolled to the study during the 48 weeks period of the study PENDING finding a lab that can perform this test (CFU quantitation). | 52 weeks | No |
| Secondary | Safety and Tolerability of TOBI podhaler | Adverse Events and Serious Adverse Events will be monitored continuously in the study and analyzed at the end of study, when enrolled to the study during the 48 weeks period of the study, plus 4 weeks wash-out. | 52 weeks | Yes |