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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01111383
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : April 13, 2018
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

No Study Results Posted on for this Study
  Recruitment Status : Completed
  Actual Primary Completion Date : May 2011
  Actual Study Completion Date : May 2011
Lewis PA. The epidemiology of cystic fibrosis. In: Hodson ME, Geddes DM. Cystic Fibrosis 2nd edition, Arnold, London 2000; 1a: 2-12.
Boat TF, Welsh MJ, Beaudet AL. Cystic fibrosis, in the metabolic basis of inherited disease (7th edn). McGraw-Hill, New York,1995.
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.

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