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Pharmacokinetic evaluation and local tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis

Pharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis - Tobra-02

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004437-16-NL
Enrollment
Unknown
Registered
2013-03-19
Start date
2013-05-15
Completion date
Unknown
Last updated
2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis Lung infections

Interventions

Product Name: Dry powder tobramycin Product Code: J01GB01 Pharmaceutical Form: Inhalation powder INN or Proposed INN: Tobramycin dry powder CAS Number: 32986-56-4 Other descriptive name: TOBRAMYCIN Co

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Age 18 years or older • Obtained informed consent • Patients having bronchiectasis (confirmed with HR-CT of the chest) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: Pregnant or breast feeding Subjects with known or suspected renal, auditory, vestibular or neuromuscular dysfunction, or with severe, active haemoptysis History of adverse events on previous tobramycin or other aminoglycoside use No concurrent use of ciclosporin, cisplatin, amfotericin B, cephalosporins, polymyxins, vancomycin and NSAIDs

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the pharmacokinetics and the local tolerabilityof dry powder tobramycin at different dosages in patients with bronchiectasis;Secondary Objective: not applicable;Primary end point(s): The following pharmacokinetic parameters will be calculated: • Actual dose (dose minus remainder in inhaler after inhalation) • AUC0-12 (area under the curve from 0 -12 h) • Cmax (maximum plasma concentration) • Tmax (time to maximum plasma concentration) • Ka absorption rate constant • T 1/2 el terminal elimination half-life • CL/F clearance following pulmonary administration (F= bioavailability) Local tolerability of the inhalation of dry powder tobramycin. Both points need to have a positive result. • Drop of FEV1 of >10% (lung function measurement) • Adverse events ;Timepoint(s) of evaluation of this end point: within four weeks after the last test dose—

Secondary

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable—

Countries

Netherlands

Contacts

Public ContactPrincipal investigatorOnno Akkerman

University Medical Center Groningen

0031503616161

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026