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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02212587
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Burkholderia Cepacia Infection Drug: TOBI Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
Study Start Date : September 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: TOBI Podhaler 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




Primary Outcome Measures :
  1. The change in sputum density of BCC in colony forming units (CFUs)/ml from day 0 to day 28 of TIP treatment. [ Time Frame: 0 to 28 days ]

Secondary Outcome Measures :
  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. [ Time Frame: 0 to 28 days ]

Other Outcome Measures:
  1. 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. [ Time Frame: 0 to 28 days ]
  2. Trough and peak sputum tobramycin concentration measured on day 28 of TIP treatment. [ Time Frame: Day 28 ]
  3. The change in BCC planktonic and biofilm MICs to tobramycin measured on day 0 and on day 28 of TIP treatment. [ Time Frame: 0 to 28 days ]
  4. The number of adverse events measured at day 14 and at day 28 of TIP treatment. [ Time Frame: At Dat 0, Day 14, and Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212587


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
St. Michael's Hospital, Toronto

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02212587    
Other Study ID Numbers: TIPBCC002
165476 ( Other Identifier: Health Canada )
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Keywords provided by St. Michael's Hospital, Toronto:
inhaled antibiotics
Additional relevant MeSH terms:
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Burkholderia Infections
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents