NCT03485456

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

March 26, 2018

Last Update Submit

September 30, 2021

Conditions

Cystic Fibrosis

Keywords

Dry powder inhalationTobramycin

Outcome Measures

Primary Outcomes (1)

  • AUC 0-12

    Area under the curve from 0 - 12 h

    0-12 hours after dry powder inhalation

Secondary Outcomes (6)

  • Cmax

    0-12 hours after dry powder inhalation

  • Tmax

    0-12 hours after dry powder inhalation

  • Ka

    0-12 hours after dry powder inhalation

  • T 1/2 el

    0-12 hours after dry powder inhalation

  • CL/F

    0-12 hours after dry powder inhalation

  • +1 more secondary outcomes

Study Arms (1)

Tobramycin

EXPERIMENTAL

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

Drug: Tobramycin

Interventions

TobramycinDRUG

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

Also known as: Tobramycin dry powder
Tobramycin

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Acute exacerbation of pulmonary infection
  • FEV1 \< 60%
  • Subjects with known or suspected renal, auditory, vestibular of neuromuscular dysfunction, or with severe, active haemoptysis
  • History of adverse events on previous tobramycin or other aminoglycoside use
  • No concurrent use of cisplatin, cyclosporine, amphotericin B, cephalosporins, polymyxins, vancomycin and NSAID's

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

NebramycinKanamycinAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Gerard Koppelman, Prof.

    University Medical Center Groningen

    STUDY CHAIR

Central Study Contacts

Anne M Akkerman-Nijland, MD

CONTACT

0031503616161a.m.akkerman-nijland@umcg.nl

Onno Akkerman, PhD

CONTACT

o.w.akkerman@umcg.nl

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 2, 2018

Study Start

May 29, 2019

Primary Completion

November 13, 2020

Study Completion

January 1, 2022

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)