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DPI-Tobra-Kind Cyclops® in Children With Cystic Fibrosis

NCT03485456 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-10-01

No results posted yet for this study

Summary

The goal is to investigate the pharmacokinetic properties of dry powder tobramycin via the Cyclops® at different dosages in children with cystic fibrosis, together with the local tolerability.

Conditions

Interventions

DRUG

Tobramycin

Tobramycin dry powder inhalation with 30, 60 and 90 mg. Nebulisation with 300 mg tobramycin

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Gerard Koppelman, Prof. · University Medical Center Groningen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2020-11-13
Completion
2022-01-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03485456 on ClinicalTrials.gov