Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer
NCT ID: NCT01116089
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2010-07-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study
NCT00420836
Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study
NCT00399945
Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin
NCT00634192
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
NCT01111383
A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
NCT00885365
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PARI LC® PLUS nebulizer
Bramitob® administered by PARI LC® PLUS nebulizer
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
PARI eFlow® rapid electronic nebulizer
Bramitob® administered by PARI eFlow® rapid electronic nebulizer
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bramitob® administered by PARI LC® PLUS nebulizer
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
Bramitob® administered by PARI eFlow® rapid electronic nebulizer
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical diagnosis of cystic fibrosis (patients registered in the National Registry of cystic fibrosis or other documents, if applicable, depending on country legislation);
* Positive response (sweat chloride concentration ≥ 60 mmol/l) in the standard sweat test documented in the clinical records or sweat chloride concentration ≥ 40 mmol/l and at least two gene mutations consistent with CF documented in the clinical records;
* Chronic colonization of Pseudomonas aeruginosa
* FEV1 ≥ 35% of the predicted normal value calculated according to the recommendation of the Official Statement of the European Respiratory Society and American Thoracic Society
Exclusion Criteria
* Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000Hz);
* Sputum culture containing Burkholderia cepacia;
* Received loop diuretics within 7 days before study drug administration;
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jozef Ružička, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fakultná nemocnica s poliklinikou Bratislava, Slovakia
Andrej Somos, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of L. Pasteur, Pneumonology Department, Rastislavova 43, 041 90, Kosice, Slovakia
Jana Skřičková, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Brno Bohunice, Jihlavská 20, 625 00, Brno, Czech Republic
Eva Beresova, M.D
Role: PRINCIPAL_INVESTIGATOR
University hospital with Health Center, F.D. Roosevelta Banská Bystrica, L. Svoboda´s square 1, 975 17, Banská Bystrica, Slovakia
Svetlana Şciuca, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
SMSI Institude of Cardiology, MD-2025, 29/1 Testimitanu str., Chisinau, Republic of Moldova
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Brno Bohunice
Brno, , Czechia
SMSI Institude of Cardiology
Chisinau, , Moldova
University hospital with Health Center
Banská Bystrica, , Slovakia
Fakultná nemocnica s poliklinikou Bratislava (FNsP)
Brastislava, , Slovakia
University Hospital of L. Pasteur, Pneumonology Department
Košice, , Slovakia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Govoni M, Poli G, Acerbi D, Santoro D, Cicirello H, Annoni O, Ruzicka J. Pharmacokinetic and tolerability profiles of tobramycin nebuliser solution 300 mg/4 ml administered by PARI eFlow((R)) rapid and PARI LC Plus((R)) nebulisers in cystic fibrosis patients. Pulm Pharmacol Ther. 2013 Apr;26(2):249-55. doi: 10.1016/j.pupt.2012.12.002. Epub 2012 Dec 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-016780-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-0908-PR-0029
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.