Clinical trial NCT01111383: A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
Official title: A Single Arm 48-Week Follow-on Safety Study to the Core Study (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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
P. aeruginosa
tobramycin
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 209
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be able to be included in the 48-week follow-on period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser solution, 300 mg twice daily in 4 mL unit dose vials).


Eligibility criteria: Inclusion Criteria:

* Successful completion of Core Study
* At least 6 years of age
* Males and females

Primary outcomes:
measure: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination.
timeFrame: up to 48 weeks
Secondary outcomes:
measure: to assess whether prolonged use of aerosolized tobramycin is required to sustain FEV1 increase (FEV1 expressed in liters and % predicted)
timeFrame: up to 48 weeks
measure: Categorical results of microbiological tests referred to P. aeruginosa (negativisation, persistence, superinfection, re-infection); susceptibility testing of isolated P. aeruginosa strains (MIC90 and MIC50)
timeFrame: up to 48 weeks
measure: Changes in body weight and BMI
timeFrame: up to 48 weeks
measure: to assess health related quality of life
timeFrame: Initial visit, Week 20, Week 44
Other outcomes:
Locations:
city: Caen
country: France
facility: CHR Clemenceau
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires
city: Paris
country: France
facility: Hopital Necker
city: Gdansk
country: Poland
facility: Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy
city: Kielce
country: Poland
facility: I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy
city: Lodz
country: Poland
facility: Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny
city: Lublin
country: Poland
facility: Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii
city: Poznan
country: Poland
facility: Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
city: Rabka Zdroj
country: Poland
facility: Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
city: Rzeszow
country: Poland
facility: Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2
city: Warszawa
country: Poland
facility: Klinika Pediatrii Instytut Matki I Dziecka
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk City Children Clinical Hospital # 2
city: Donetsk
country: Ukraine
facility: Donetsk Regional Children Clinical Hospital
city: Kriviy Rig
country: Ukraine
facility: Kriviy Rig City Clinical Hospital # 8
city: Kyiv
country: Ukraine
facility: Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine
city: Kyiv
country: Ukraine
facility: Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine
city: Lviv
country: Ukraine
facility: Lviv Regional Children Specialized Clinical Hospital
city: Odesa
country: Ukraine
facility: Odesa Regional Children Clinical Hospital
city: Simferopol
country: Ukraine
facility: Simferopol Central District Clinical Hospital
city: Zaporizhya
country: Ukraine
facility: Zaporizhya Regional Clinical Children Hospital
Study officials:
affiliation: Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
name: Henryk Mazurek, Doctor
role: PRINCIPAL_INVESTIGATOR
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