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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Minocycline; Tobramycin

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