A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
NCT ID: NCT01111383
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
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COMPLETED
PHASE3
209 participants
INTERVENTIONAL
2009-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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tobramycin
300mg/4ml solution, via a nebuliser, over a 48-week period in a twice-daily regimen, with 6 "on" cycles of 4 weeks duration during the 48-week period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 6 years of age
* Males and females
6 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Henryk Mazurek, Doctor
Role: PRINCIPAL_INVESTIGATOR
Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
Locations
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CHR Clemenceau
Caen, , France
Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires
Montpellier, , France
Hopital Necker
Paris, , France
Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy
Gdansk, , Poland
I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy
Kielce, , Poland
Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny
Lodz, , Poland
Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii
Lublin, , Poland
Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
Poznan, , Poland
Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
Rabka-Zdrój, , Poland
Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2
Rzeszów, , Poland
Klinika Pediatrii Instytut Matki I Dziecka
Warsaw, , Poland
Dnipropetrovsk City Children Clinical Hospital # 2
Dnipropetrovsk, , Ukraine
Donetsk Regional Children Clinical Hospital
Donetsk, , Ukraine
Kriviy Rig City Clinical Hospital # 8
Kryvyi Rih, , Ukraine
Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine
Kyiv, , Ukraine
Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine
Kyiv, , Ukraine
Lviv Regional Children Specialized Clinical Hospital
Lviv, , Ukraine
Odesa Regional Children Clinical Hospital
Odesa, , Ukraine
Simferopol Central District Clinical Hospital
Simferopol, , Ukraine
Zaporizhya Regional Clinical Children Hospital
Zaporizhya, , Ukraine
Countries
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References
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Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999 Jan 7;340(1):23-30. doi: 10.1056/NEJM199901073400104.
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Related Links
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Study Record on EU Clinical Trials Register including results
Other Identifiers
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CMA-0631-PR-0010 Extension
Identifier Type: -
Identifier Source: org_study_id
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