A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® (CT03Ext)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01111383
First received: April 13, 2010
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

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).


Condition Intervention Phase
Cystic Fibrosis
Drug: tobramycin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • 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. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to assess whether prolonged use of aerosolized tobramycin is required to sustain FEV1 increase (FEV1 expressed in liters and % predicted) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Categorical results of microbiological tests referred to P. aeruginosa (negativisation, persistence, superinfection, re-infection); susceptibility testing of isolated P. aeruginosa strains (MIC90 and MIC50) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Changes in body weight and BMI [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • to assess health related quality of life [ Time Frame: Initial visit, Week 20, Week 44 ] [ Designated as safety issue: No ]

Enrollment: 209
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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 Name: Tobrineb®/Actitob®/Bramitob®
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successful completion of Core Study
  • At least 6 years of age
  • Males and females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111383

Locations
France
CHR Clemenceau
Caen, France, 14 033
Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires
Montpellier, France, 34 295
Hopital Necker
Paris, France, 75 015
Poland
Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy
Gdansk, Poland, 80-308
I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy
Kielce, Poland, 25-381
Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny
Lodz, Poland, 93-513
Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii
Lublin, Poland, 20-093
Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
Poznan, Poland, 60-572
Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
Rabka Zdroj, Poland, 34-700
Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2
Rzeszow, Poland, 35-301
Klinika Pediatrii Instytut Matki I Dziecka
Warszawa, Poland, 01-211
Ukraine
Dnipropetrovsk City Children Clinical Hospital # 2
Dnipropetrovsk, Ukraine, 49101
Donetsk Regional Children Clinical Hospital
Donetsk, Ukraine, 83052
Kriviy Rig City Clinical Hospital # 8
Kriviy Rig, Ukraine, 50047
Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine
Kyiv, Ukraine, 03680
Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine
Kyiv, Ukraine, 04050
Lviv Regional Children Specialized Clinical Hospital
Lviv, Ukraine, 79035
Odesa Regional Children Clinical Hospital
Odesa, Ukraine, 65031
Simferopol Central District Clinical Hospital
Simferopol, Ukraine, 95033
Zaporizhya Regional Clinical Children Hospital
Zaporizhya, Ukraine
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Henryk Mazurek, Doctor Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
  More Information

Publications:
Lewis PA. The epidemiology of cystic fibrosis. In: Hodson ME, Geddes DM. Cystic Fibrosis 2nd edition, Arnold, London 2000; 1a: 2-12.
Høiby N. Microbiology of lung infections in cystic fibrosis patients. Acta Paediatr Scand 1982; 301: 33-54.
Ramsey BW, Schaeffler BL, Montgomery AB, et al. Survival and lung function during two years of treatment with intermittent tobramycin solution for inhalation in CF patients. Presented at European Cystic Fibrosis Conference (June 1999), The Hague, The Netherlands.
Van Dalfsen JM, Lin L, Burns JL, et al. Microbiology effect of 18 months of intermittent inhaled tobramycin in patients with CF. Presented at European Cystic Fibrosis Conference (June 1999), The Hague, The Netherlands.
Lenoir G, Aryayev N, et al. Highly concentrated aerosolized Tobramycin in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection. Eur. Respir. J 2005:26 (suppl. 49) 620s.
Chuchalin A, Gyurkovics K, et al. Long term administration of aerosolised tobramycin, in patients with cystic fibrosis. Eur. Respir. J.2005: 26 (suppl 49) 3942s.

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01111383     History of Changes
Other Study ID Numbers: CMA-0631-PR-0010 Extension
Study First Received: April 13, 2010
Last Updated: November 18, 2011
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Ukraine: State Pharmacological Center - Ministry of Health
France: Institutional Ethical Committee

Keywords provided by Chiesi Farmaceutici S.p.A.:
cystic fibrosis
P. aeruginosa
tobramycin

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014