Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex

Study Overview
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Brief Summary
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The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of cystic fibrosis patient.

Official Title
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Pilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex

Conditions
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Cystic Fibrosis, Burkholderia Cepacia Infection

Intervention / Treatment
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* Drug: TOBI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 years or older Diagnosis of CF based on the following: sweat chloride>60 mEq/L or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF. Chronically infected with a Burkholderia cepacia complex species (>50% of respiratory specimens positive in the 24 months prior to screening). Able to produce sputum (expectorated or induced). Able to reproducibly perform pulmonary function testing. Written informed consent provided. Exclusion Criteria: Post lung transplantation. Pregnancy. Acute exacerbation requiring IV or oral antibiotics within 14 days Patients currently receiving inhaled tobramycin/TOBI A septic or clinically unstable patient, as determined by the investigator.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOBI Podhaler<br> | Drug: TOBI<br>* New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Sputum Density of BCC in Colony Forming Units (CFUs)/ml From Day 0 to Day 28 of TIP Treatment. | The change in sputum density of BCC in colony forming units (CFUs)/ml from day 0 to day 28 of TIP treatment. Sputum density was calculated by doing serial dilutions of sputum on agar plates and counting colony forming units expressed per ml. | 0 to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Pulmonary Function Tests, Including Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC) and Maximal Mid-expiratory Flow Rate (FEF25-75), Measured at Day 0 and Day 28 of TIP Treatment. | The main lung function measure was relative change in FEV1 from day 0 to Day 28 reported as %. | 0 to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inhaled antibiotics