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

April 13, 2010
November 18, 2011
September 2009
May 2011   (final data collection date for primary outcome 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. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01111383 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
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)

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).

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cystic Fibrosis
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®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
209
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successful completion of Core Study
  • At least 6 years of age
  • Males and females
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Poland,   Ukraine
 
NCT01111383
CMA-0631-PR-0010 Extension
No
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Principal Investigator: Henryk Mazurek, Doctor Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
Chiesi Farmaceutici S.p.A.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP