Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2013-004488-30-NL
• Date of registration: 11/12/2013
• Prospective Registration: Yes
• Primary sponsor: Haga Hospital
• Public title: Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)
• Scientific title: Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CF
• Date of first enrolment: 31/01/2014
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004488-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Tobramycin nebulisation with PariLCPlus nebuliser compared to Akita nebuliser Number of treatment arms in the trial: 2

Countries of recruitment

Netherlands

Contacts

• Name: AJ van Velzen
• Affiliation: Haga Hospital

• Name: AJ van Velzen
• Affiliation: Haga Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Age = 18 years;
• FEV1 predicted = 30%;
• Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
• Chronic PA colonization requiring maintenance therapy with inhaled tobramycin;
• Ability to breathe through a mouthpiece and to use the inhaler;
• Ability to perform lung function tests;
• Written informed consent.

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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Severe acute exacerbation of pulmonary infection (needing intravenous treatment);
• Known impaired kidney function (estimated creatinine clearance < 60 ml/min);
• Known aminoglycoside hypersensitivity;
• Therapy (e.g. furosemide) or disease which may complicate evaluation of the study protocol, as judged by the investigator;
• Participation in another drug-investigating clinical study at the start or within 1 month prior to the start;
• Inability to follow instructions of the investigator.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic fibrosis

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Trade Name: Bramitob
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: TOBRAMYCIN
CAS Number: 32986-56-4
Current Sponsor code: TAPAS-PK-2014
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 600-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 1 year

Main Objective: To investigate the pharmacokinetics of once daily inhalation of the recommended daily dose of tobramycin with the Akita® nebulizer, specifically targeted to the peripheral small airways, in patients with CF.

Primary end point(s): Systemic bioavailability of inhaled tobramycin, defined as serum tobramycin AUC0-24hr.

Secondary Objective: To compare data from primary objective to 1) pharmacokinetics of once daily tobramycin inhalation with the conventional and registered PARI-LC® Plus nebulizer and to 2) pharmacokinetic data from the literature about standard twice daily tobramycin inhalation with the PARI-LC® Plus.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1 year

Secondary end point(s): • Serum tobramycin peak and trough levels;
• Adverse events.

Secondary ID(s)

TAPAS-PK-2014

Source(s) of Monetary Support

Haga Hospital