Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection
Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa
Intervention: Tobramycin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Rabin Medical Center Official(s) and/or principal investigator(s): Mordechai R Kramer, MD, Study Chair, Affiliation: Rabin Medical Center
Overall contact: Mordechai Kramer, Prof, Phone: 050-5710702, Email: Kremerm@clalit.org.il
Summary
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.
Clinical Details
Official title: Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of exacerbations as measured by number of systemic courses of antibiotics either PO or IV
Secondary outcome: 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 domainsPulmonary function tests (FEV1) Sputum microbiology: Change in Pseudomona Aeruginosa density in sputum Safety and Tolerability of TOBI podhaler
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Mordechai Kramer, Prof, Phone: 050-5710702, Email: Kremerm@clalit.org.il
Pulmonary Institute, Rabin Medical Center, Beilinson Campus, Petach Tikva 49100, Israel; Not yet recruiting Mordechai Kramer, Prof, Principal Investigator Leonardo Fuks, Dr, Sub-Investigator
Additional Information
Related publications: 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. 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. 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.
Starting date: April 2014
Last updated: March 30, 2014
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