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NCT Number: NCT02212587

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

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.

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Key information

Conditions

Cystic Fibrosis Bacterial Infections Bacterial Infections and Mycoses Burkholderia Cepacia Infection Burkholderia Infections Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital for Sick Children, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TOBI

Drug

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 outcomes

  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

    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 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.

    Time frame: 0 to 28 days

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

Other outcomes

  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

    We measured both neutrophil elastase sputum for participants.

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

    Time frame: Day 28

    We did trough (0 hour) and peak (1 hour post dose) TIP sputum tobramycin concentrations and reported it for participants.

  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

    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.

  4. The Number of Participants With Adverse Events Measured at Day 14 and at Day 28 of TIP Treatment.

    Time frame: At Dat 0, Day 14, and Day 28

    The number of participants with adverse events was reported for all participants in the trial.

  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.

    Time frame: 0 to 28 days

    We measured both IL-8 sputum for participants.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2014
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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