A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

Phase 3

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT01111383
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	up to 48 weeks

Secondary Outcome Measures

Name	Time	Method
to assess whether prolonged use of aerosolized tobramycin is required to sustain FEV1 increase (FEV1 expressed in liters and % predicted)	up to 48 weeks
to assess health related quality of life	Initial visit, Week 20, Week 44
Categorical results of microbiological tests referred to P. aeruginosa (negativisation, persistence, superinfection, re-infection); susceptibility testing of isolated P. aeruginosa strains (MIC90 and MIC50)	up to 48 weeks
Changes in body weight and BMI	up to 48 weeks

Trial Locations

Locations (20)

I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy; 🇵🇱 Kielce, Poland

Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii; 🇵🇱 Lublin, Poland

Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj; 🇵🇱 Rabka Zdroj, Poland

Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine; 🇺🇦 Kyiv, Ukraine

Donetsk Regional Children Clinical Hospital; 🇺🇦 Donetsk, Ukraine

Kriviy Rig City Clinical Hospital # 8; 🇺🇦 Kriviy Rig, Ukraine

Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine; 🇺🇦 Kyiv, Ukraine

Odesa Regional Children Clinical Hospital; 🇺🇦 Odesa, Ukraine

Zaporizhya Regional Clinical Children Hospital; 🇺🇦 Zaporizhya, Ukraine

Hopital Necker; 🇫🇷 Paris, France

CHR Clemenceau; 🇫🇷 Caen, France

Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy; 🇵🇱 Gdansk, Poland

Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires; 🇫🇷 Montpellier, France

Klinika Pediatrii Instytut Matki I Dziecka; 🇵🇱 Warszawa, Poland

Lviv Regional Children Specialized Clinical Hospital; 🇺🇦 Lviv, Ukraine

Simferopol Central District Clinical Hospital; 🇺🇦 Simferopol, Ukraine

Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2; 🇵🇱 Rzeszow, Poland

Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu; 🇵🇱 Poznan, Poland

Dnipropetrovsk City Children Clinical Hospital # 2; 🇺🇦 Dnipropetrovsk, Ukraine

Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny; 🇵🇱 Lodz, Poland