Pharmacokinetic evaluation and tolerability of dry powder tobramycin via the Cyclops® in children with cystic fibrosis

Pharmacokinetic evaluation and tolerability of dry powder tobramycin via the Cyclops® in children with cystic fibrosis - DPI-tobra-child

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50074

Enrollment

Registered

2020-04-09

Start date

2018-08-15

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Cystic Fibrosis

Interventions

Dry powder inhalation

Tobramycin

All patients have to inhale dry powder tobramycin via the Cyclops in three different dosages, and once tobramycin via wet nebulization.

Cystic Fibrosis

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Clinical diagnosis of CF and a positive sweat test or two CF-related mutations - Age 6 - 18 years - Ability to breathe through a mouthpiece and to use the Cyclops - Ability to perform pulmonary function tests - Written informed consent (child and parents)

Exclusion criteria

Exclusion criteria: - Acute exacerbation - FEV1

Design outcomes

Primary

Measure	Time frame
The following pharmacokinetic parameters will be calculated: AUC0 till 8-12 (area under the curve from 0 till 8-12 h)	—

Secondary

Measure	Time frame
The following pharmacokinetic parameters will be calculated: actual dose (dose minus remainder in inhaler after inhalation), Cmax (maximum plasma concentration), Tmax (time to maximum plasma concentration), Ka (absorption rate constant), T1/2 el (terminal elimination half-life), CL/F (clearance following pulmonary administration (F= bioavailability)). Local tolerability of DP Tobramycin is determined by scoring adverse events, specifically coughing, and lung function measurement.	—

Measure

Time frame

The following pharmacokinetic parameters will be calculated: actual dose (dose minus remainder in inhaler after inhalation), Cmax (maximum plasma concentration), Tmax (time to maximum plasma concentration), Ka (absorption rate constant), T1/2 el (terminal elimination half-life), CL/F (clearance following pulmonary administration (F= bioavailability)). Local tolerability of DP Tobramycin is determined by scoring adverse events, specifically coughing, and lung function measurement.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)