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

Phase 1

Completed

• Conditions: Burkholderia Cepacia Infection; Cystic Fibrosis
• Interventions: Drug: TOBI

• Registration Number: NCT02212587
• Lead Sponsor: Unity Health Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-08
• Study Start: 2014-09
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2018-08-21
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-12
• Last Update Submitted: 2020-10-12
• Results First Posted: 2020-11-04
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOBI Podhaler	TOBI	-

Primary Outcome Measures

Name	Time	Method
The Change in Sputum Density of BCC in Colony Forming Units (CFUs)/ml From Day 0 to Day 28 of TIP Treatment.	0 to 28 days	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.

Secondary Outcome Measures

Name	Time	Method
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.	0 to 28 days	The main lung function measure was relative change in FEV1 from day 0 to Day 28 reported as %.

Trial Locations

Locations (2)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada