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

Phase 1

• Conditions: Cystic FibrosisLung infections; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-005014-21-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-31
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 10

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)
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Acute exacerbation
- 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 amino
glycoside use
- History of adverse events on the use of powder inhaler
- Concurrent use of cyclosporine, amphotericin B, cephalosporins,
polymyxins, vancomycin and NSAID's

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified