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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212587
• Other study ID #: TIPBCC002
• Secondary ID: 165476
• Status: Completed
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2020
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burkholderia Cepacia Infection
• Burkholderia Infections
• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• TOBI
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

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Waters V, Yau Y, Beaudoin T, Wettlaufer J, Tom SK, McDonald N, Rizvi L, Klingel M, Ratjen F, Tullis E. Pilot trial of tobramycin inhalation powder in cystic fibrosis patients with chronic Burkholderia cepacia complex infection. J Cyst Fibros. 2017 Jul;16( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Change in the Measurement of Markers of Pulmonary Inflammation (Neutrophil Counts, Neutrophil Elastase and IL-8 Levels in Sputum) Measured at Day 0 and Day 28 of TIP Treatment.	We measured both neutrophil elastase sputum for participants.	0 to 28 days
Other	Trough and Peak Sputum Tobramycin Concentration Measured on Day 28 of TIP Treatment.	We did trough (0 hour) and peak (1 hour post dose) TIP sputum tobramycin concentrations and reported it for participants.	Day 28
Other	The Change in BCC Planktonic and Biofilm MICs to Tobramycin Measured on Day 0 and on Day 28 of TIP Treatment.	For all participants, the minimum inhibitory concentration of tobramycin for planktonic and biofilm grown BCC was measured in the lab on the isolate collected before and after TIP treatment.	0 to 28 days
Other	The Number of Participants With Adverse Events Measured at Day 14 and at Day 28 of TIP Treatment.	The number of participants with adverse events was reported for all participants in the trial.	At Dat 0, Day 14, and Day 28
Other	The Change in the Measurement of Markers of Pulmonary Inflammation (Neutrophil Counts, Neutrophil Elastase and IL-8 Levels in Sputum) Measured at Day 0 and Day 28 of TIP Treatment.	We measured both IL-8 sputum for participants.	0 to 28 days
Primary	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	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

External Links

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