Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection

NCT02102152 | Unknown DMC

• 1 other identifier: RMCBH147441
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa

Keywords

Tobramycin Podhaler; bronchiectasis; chronic infection; Pseudomonas Aeruginosa

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

  52 weeks

• Pulmonary function tests (FEV1)

  52 weeks

• Sputum microbiology: Change in Pseudomona Aeruginosa density in sputum

  52 weeks

• Safety and Tolerability of TOBI podhaler

  52 weeks

Study Arms (2)

TOBI / Placebo

ACTIVE COMPARATOR

TOBI / Placebo.

Drug: Tobramycin

Placebo / TOBI

ACTIVE COMPARATOR

Placebo / TOBI

Drug: Tobramycin

Interventions

Tobramycin DRUG

Placebo / TOBI; TOBI / Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bronchiectasis confirmed by CT
• Chronic PA colonization with 2 documented sputum cultures positive for PA in the last 24 months.
• Age \>=18

You may not qualify if:

• Patients diagnosed with CF
• Patients who do not tolerate Tobramycin
• Pregnant or breastfeeding
• Patients treated in the last 8 weeks with antibiotic therapy either inhaled or systemic (excluding Azenil PO x 3/week which is allowed)

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Pulmonary Institute, Rabin Medical Center, Beilinson Campus

Petah Tikva, 49100, Israel

Location

Related Publications (3)

• 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.

  PMID: 15821224 BACKGROUND

• 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.

  PMID: 21075062 BACKGROUND

• 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.

  PMID: 17443506 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis; Persistent Infection; Pseudomonas Infections

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Mordechai R Kramer, MD

  Rabin Medical Center

  STUDY CHAIR

Central Study Contacts

Mordechai Kramer, Prof

CONTACT

050-5710702; Kremerm@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pulmunary Institute

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: April 2, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 2, 2014

Record last verified: 2014-03

Locations

IL (1)