Bronchiectasis MedDRA version: 14.1 Level: LLT Classification code 10006446 Term: Bronchiectasis NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: TOBI 300 mg/5 ml verneveloplossing
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: TOBRAMYCIN
CAS Number: 32986-56-4
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
Vu University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Bronchiectasis Antibiotic inhalation treatment 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 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3 ;Inclusion criteria: Bronchiectasis Antibiotic inhalation treatment 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 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: o Age 50 mmHg, WHO Global Initiative for Chronic Obstructive Lung Disease 2006) o Renal insufficiency defined as renal creatinine clearance of 50 mmHg, WHO Global Initiative for Chronic Obstructive Lung Disease 2006) o Renal insufficiency defined as renal creatinine clearance of < 30 ml/minute. o Neuromuscular diseases. o Impaired hearing o Pregnant or breastfeeding. o Bronchiectasis exacerbation during last 4 weeks. o History of panic attacks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of CO2 enriched ambient air on deposition of inhaled tobramycin in bronchiectasis patients. ;Secondary Objective: To asses (with planar imaging) whether SPECT/CT scan are feasible in assessing pulmonary deposition of inhaled tobramycin. To compare pulmonary deposition of tobramycin with the Pari LC Plus ® nebulizer and the Aero Eclipse II ® nebulizer;Primary end point(s): o Mean clearance rate (and range) of 99mTc-DTPA o Total and peripheral deposition of inhaled tobramycin (with and without carbon dioxide and with two different nebulizers) o Pharmacokinetics: C max (peak concentration), AUC (0-8 hours), T max (time to reach maximum concentration), T1/2 (half life). ;Timepoint(s) of evaluation of this end point: End of the study;Main Objective: To evaluate the effect of CO2 enriched ambient air on deposition of inhaled tobramycin in bronchiectasis patients. ;Secondary Objective: To asses (with planar imaging) whether SPECT/CT scan are feasible in assessing pulmonary deposition of inhaled tobramycin. To compare pulmonary deposition of tobramycin with the Pari LC Plus ® nebulizer and the Aero Eclipse II ® nebulizer;Primary end point(s): o Mean clearance rate (and range) of 99mTc-DTPA o Total and peripheral deposition of inhaled tobramycin (with and without carbon dioxide and with two different nebulizers) o Pharmacokinetics: C max (peak concentration), AUC (0-8 hours), T max (time to reach maximum concentration), T1/2 (half life). ;Timepoint(s) of evaluation of this end point: End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Peak expiratory flow o Respiratory parameters o Borg score (subjective sensation of dyspnoea) ;Timepoint(s) of evaluation of this end point: End of study;Secondary end point(s): o Peak expiratory flow o Respiratory parameters o Borg score (subjective sensation of dyspnoea) ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Netherlands
Contacts
Public ContactInformation on clinical trial;Information on clinical trial ;
VU University Medical Center;VU University Medical Center
Outcome results
None listed