Clinical trial NCT02102152: Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection
Official title: Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa
Keywords: Tobramycin Podhaler
bronchiectasis
chronic infection
Pseudomonas Aeruginosa
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Number of exacerbations as measured by number of systemic courses of antibiotics either PO or IV
timeFrame: 52 weeks total
Secondary outcomes:
measure: 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
timeFrame: 52 weeks
measure: Pulmonary function tests (FEV1)
timeFrame: 52 weeks
measure: Sputum microbiology: Change in Pseudomona Aeruginosa density in sputum
timeFrame: 52 weeks
measure: Safety and Tolerability of TOBI podhaler
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Pulmonary Institute, Rabin Medical Center, Beilinson Campus
Study officials:
affiliation: Rabin Medical Center
name: Mordechai R Kramer, MD
role: STUDY_CHAIR
References:
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. doi: 10.1378/chest.127.4.1420.
citation: 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.
citation: Evans DJ, Bara AI, Greenstone M. Prolonged antibiotics for purulent bronchiectasis in children and adults. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001392. doi: 10.1002/14651858.CD001392.pub2.