NCT02212587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

November 4, 2020

Completed
Last Updated

November 4, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

August 6, 2014

Results QC Date

August 21, 2018

Last Update Submit

October 12, 2020

Conditions

Cystic FibrosisBurkholderia Cepacia Infection

Keywords

inhaled antibiotics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Other Outcomes (5)

  • 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.

    0 to 28 days

  • Trough and Peak Sputum Tobramycin Concentration Measured on Day 28 of TIP Treatment.

    Day 28

  • The Change in BCC Planktonic and Biofilm MICs to Tobramycin Measured on Day 0 and on Day 28 of TIP Treatment.

    0 to 28 days

  • +2 more other outcomes

Study Arms (1)

TOBI Podhaler

EXPERIMENTAL
Drug: TOBI

Interventions

TOBIDRUG

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

TOBI Podhaler

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related 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(4):492-495. doi: 10.1016/j.jcf.2017.02.008. Epub 2017 Mar 3.

    PMID: 28262569RESULT

MeSH Terms

Conditions

Cystic FibrosisBurkholderia Infections

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Dr. Valerie Waters
Organization
Hospital of Sick Children
valerie.waters@sickkids.ca
416-813-1500

Study Officials

  • Valerie Waters, MD

    Hospital of Sick Children

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 8, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 4, 2020

Results First Posted

November 4, 2020

Record last verified: 2020-10

Locations

CA(2)