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 | Completed Phase 3

• 1 other identifier: CMA-0631-PR-0010 Extension
• Study Type: interventional
• Target: 209
• Locations: 3 countries
• Sites: 20

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).

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; P. aeruginosa; tobramycin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• to assess whether prolonged use of aerosolized tobramycin is required to sustain FEV1 increase (FEV1 expressed in liters and % predicted)

  up to 48 weeks

• 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

• to assess health related quality of life

  Initial visit, Week 20, Week 44

Interventions

tobramycin DRUG

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.

Also known as: Tobrineb®/Actitob®/Bramitob®

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (20)

CHR Clemenceau

Caen, 14 033, France

Location

Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires

Montpellier, 34 295, France

Location

Hopital Necker

Paris, 75 015, France

Location

Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy

Gdansk, 80-308, Poland

Location

I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy

Kielce, 25-381, Poland

Location

Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny

Lodz, 93-513, Poland

Location

Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii

Lublin, 20-093, Poland

Location

Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

Poznan, 60-572, Poland

Location

Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj

Rabka-Zdrój, 34-700, Poland

Location

Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2

Rzeszów, 35-301, Poland

Location

Klinika Pediatrii Instytut Matki I Dziecka

Warsaw, 01-211, Poland

Location

Dnipropetrovsk City Children Clinical Hospital # 2

Dnipropetrovsk, 49101, Ukraine

Location

Donetsk Regional Children Clinical Hospital

Donetsk, 83052, Ukraine

Location

Kriviy Rig City Clinical Hospital # 8

Kryvyi Rih, 50047, Ukraine

Location

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

Kyiv, 03680, Ukraine

Location

Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine

Kyiv, 04050, Ukraine

Location

Lviv Regional Children Specialized Clinical Hospital

Lviv, 79035, Ukraine

Location

Odesa Regional Children Clinical Hospital

Odesa, 65031, Ukraine

Location

Simferopol Central District Clinical Hospital

Simferopol, 95033, Ukraine

Location

Zaporizhya Regional Clinical Children Hospital

Zaporizhya, Ukraine

Location

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Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Henryk Mazurek, Doctor

  Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 27, 2010
• Study Start: September 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

UA (9); FR (3); PL (8)