E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bronchiectasis |
Bronchiëctasieën |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic lung damage |
Chronische longschade |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006446 |
E.1.2 | Term | Bronchiectasis NOS |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of CO2 enriched ambient air on deposition of inhaled tobramycin in bronchiectasis patients.
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Evalueren van het effect van CO2 verrijkte omgevingslucht op de depositie van tobramycine inhalatie in patiënten met bronchiëctasieën.
|
|
E.2.2 | Secondary objectives of the trial |
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 |
Evalueren van de mogelijkheid tot bepalen van de pulmonale depositie van tobramycine inhalatie met SPECT/CT scans
Vergelijken van de pulmonale depositie van tobramycine inhalatie met de Pari LC Plus ® vernevelaar en de Aero Eclipse II ® vernevelaar. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Bronchiectasis Antibiotic inhalation treatment |
Bronchiëctasieën Behandeling met inhalatie antibioticum |
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E.4 | Principal exclusion criteria |
o Age <21 years. o Chronic respiratory insufficiency defined according to the GOLD criteria (PaO2 < 60 mmHg or PaCO2 > 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
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o leeftijd <21 jaar. o Chronische respiratoire insufficientie (volgens GOLD richtlijnen (PaO2 < 60 mmHg or PaCO2 > 50 mmHg, WHO Global Initiative for Chronic Obstructive Lung Disease 2006) o Nierinsufficiëntie gedefinieerd als kreatinine klaring van < 30 ml/minuut o Neuromusculaire ziekte. o Gehoorverlies o Zwangerschap en borstvoeding. o Exacerbation gedurende afgelopen 4 weken. o Paniekaanvallen in de voorgeschiedenis |
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E.5 End points |
E.5.1 | 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).
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o Gem. klarings rate (en range) van 99mTc-DTPA o Totale en perifere depositie van tobramycine inhalatie (met en zonder koolstofdioxide en twee verschillende vernevelaars) o Farmacokinetiek: C max (piek concentratie), AUC (0-8 uur), T max (tijd tot max concentratie), T1/2 (halfwaardetijd). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of the study |
Eind van de studie |
|
E.5.2 | Secondary end point(s) |
o Peak expiratory flow o Respiratory parameters o Borg score (subjective sensation of dyspnoea)
|
o Peak expiratory flow o Respiratoire parameters o Borg score (subjectieve sensatie van dyspnoe) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of study |
Eind van de studie |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
IMP met en onder CO2 verrijkte omgevingslucht (1); 2 verschillende vernevelaars andere dosis (2) |
IMP with and without CO2 enriched ambient air (1); 2 different nebulizers with different dose (2) |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of last subject of the trial. |
Laatste studiebezoek van de laatste proefpersoon in het onderzoek. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |