Status:
UNKNOWN
DPI-Tobra-Kind Cyclops® in Children With Cystic Fibrosis
Lead Sponsor:
University Medical Center Groningen
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-18 years
Phase:
PHASE1
PHASE2
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.
Detailed Description
Rationale: Cystic fibrosis is the most common life-shortening autosomal recessive disease among Caucasian populations. It is a chronic progressive disease causing deterioration of pulmonary function, ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03485456
Start Date
May 29 2019
End Date
January 1 2022
Last Update
October 1 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Center Groningen
Groningen, Netherlands