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Sponsored by: |
Chiesi Farmaceutici S.p.A. |
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Information provided by: | Chiesi Farmaceutici S.p.A. |
ClinicalTrials.gov Identifier: | NCT00885365 |
The purpose of this study is to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in primary efficacy variable, forced expiratory volume in one second (FEV₁) percent of predicted normal, and to compare their safety in patients with cystic fibrosis and chronic infection of the lungs with P. aeruginosa.
Condition | Intervention | Phase |
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Cystic Fibrosis |
Drug: tobramycin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa |
Estimated Enrollment: | 320 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Tobrineb®/Actitob®/Bramitob®, tobramycin 300mg/4ml solution
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Drug: tobramycin
300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen
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2: Active Comparator
TOBI® Nebuliser tobramycin 300mg/5 ml solution
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Drug: tobramycin
300mg/5 ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen
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Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Guido Varoli | +39 0521-279718 | g.varoli@chiesigroup.com |
Contact: Helen Cicirello, MD | +301-424-2661 | hcicirello@chiesiusa.com |
Principal Investigator: | Henryk Mazurek, Doctor | Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj |
Responsible Party: | Klinika Pneumonologii i Mukowiscydozy, Instytutu Gruzlicy i Chorob Pluc w Rabce Zdroj ( Dr. Henryk Mazurek ) |
Study ID Numbers: | CMA-0631-PR-0010 |
Study First Received: | April 20, 2009 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00885365 History of Changes |
Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Ukraine: State Pharmacological Center - Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Czech Republic: State Institute for Drug Control; Russia: Ministry of Health and Social Development of the Russian Federation; Spain: Spanish Agency of Medicines |
cystic fibrosis P. aeruginosa tobramycin |
Anti-Infective Agents Anti-Bacterial Agents Digestive System Diseases Tobramycin Genetic Diseases, Inborn Respiratory Tract Diseases |
Cystic Fibrosis Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |
Anti-Infective Agents Tobramycin Fibrosis Pharmacologic Actions Anti-Bacterial Agents Digestive System Diseases Pathologic Processes |
Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Therapeutic Uses Pancreatic Diseases Infant, Newborn, Diseases |