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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03485456
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Onno Akkerman, University Medical Center Groningen

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Tobramycin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin Via the Cyclops® in Children With Cystic Fibrosis
Actual Study Start Date : May 29, 2019
Actual Primary Completion Date : November 13, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Tobramycin
Tobramycin dry powder inhalation with 30, 60 and 90 mg. Nebulisation with 300 mg tobramycin
Drug: Tobramycin
Tobramycin dry powder inhalation with 30, 60 and 90 mg. Nebulisation with 300 mg tobramycin
Other Name: Tobramycin dry powder




Primary Outcome Measures :
  1. AUC 0-12 [ Time Frame: 0-12 hours after dry powder inhalation ]
    Area under the curve from 0 - 12 h


Secondary Outcome Measures :
  1. Cmax [ Time Frame: 0-12 hours after dry powder inhalation ]
    maximum plasma concentration

  2. Tmax [ Time Frame: 0-12 hours after dry powder inhalation ]
    Time to maximum plasma concentration

  3. Ka [ Time Frame: 0-12 hours after dry powder inhalation ]
    Absorption rate constant

  4. T 1/2 el [ Time Frame: 0-12 hours after dry powder inhalation ]
    Terminal elimination half-life

  5. CL/F [ Time Frame: 0-12 hours after dry powder inhalation ]
    Clearance following pulmonary administration

  6. Local tolerability [ Time Frame: Before and 15, 30 and 90 minutes after inhalation ]
    Local tolerability determined by scoring adverse events, specifically coughing, and lung function



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485456


Contacts
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Contact: Anne M Akkerman-Nijland, MD 0031503616161 a.m.akkerman-nijland@umcg.nl
Contact: Onno Akkerman, PhD o.w.akkerman@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Anne Akkerman-Nijland, Drs.         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Study Chair: Gerard Koppelman, Prof. University Medical Center Groningen
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Responsible Party: Onno Akkerman, Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03485456    
Other Study ID Numbers: DPI-Tobra-Kind
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Onno Akkerman, University Medical Center Groningen:
Dry powder inhalation
Tobramycin
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents