Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005346-20-GB

Enrollment

Registered

2007-11-28

Start date

2007-12-04

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with cystic fibrosis

Interventions

Trade Name: Tobi 300 mg/5 ml Nebuliser Solution Product Name: TOBI Pharmaceutical Form: Nebuliser solution INN or Proposed INN: tobramycin Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children under the age of 18 with Cystic Fibrosis on routine nebulised tobramycin (TOBI) treatment via e-flow delivery system. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients receiving intravenous tobramycin.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether nebulised tobramycin via e flow delivery system causes raised serum tobramycin levels at 1 hour?;Secondary Objective: Is there any increased renal toxicity in these patients as observed by raised urine NAG (N acetyl beta D glucosaminidase) enzyme levels? Is there any increased oto toxicity in these patients observed by change in auditory acuity (defined by bilateral decrease of 15 dB or more) in routine yearly audiology testing? Are there implications for timings of nebulisers and tobramycin levels in patients on intravenous tobramycin? Should the nebulised dose of tobramycin via e flow be adjusted? ;Primary end point(s): To determine whether nebulised tobramycin via e flow delivery system causes raised serum tobramycin levels at 1 hour.	—

Measure

Time frame

Main Objective: To determine whether nebulised tobramycin via e flow delivery system causes raised serum tobramycin levels at 1 hour?;Secondary Objective: Is there any increased renal toxicity in these patients as observed by raised urine NAG (N acetyl beta D glucosaminidase) enzyme levels? Is there any increased oto toxicity in these patients observed by change in auditory acuity (defined by bilateral decrease of 15 dB or more) in routine yearly audiology testing? Are there implications for timings of nebulisers and tobramycin levels in patients on intravenous tobramycin? Should the nebulised dose of tobramycin via e flow be adjusted? ;Primary end point(s): To determine whether nebulised tobramycin via e flow delivery system causes raised serum tobramycin levels at 1 hour.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026