A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo (EDIT)


Tracking Information

Start Date  ICMJEJune 2009
Estimated Primary Completion DateFebruary 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: June 10, 2009)		Relative change from baseline FEV1 percent predicted compared to placebo [ Time Frame: Day 29 of on-treatment period of cycle 1 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00918957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: June 10, 2009)
  • Safety profile of TIPnew [ Time Frame: As reported until 4 weeks post study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic properties of tobramycin from TIPnew [ Time Frame: Days 1 and 29 ] [ Designated as safety issue: Yes ]
  • Density of microorganisms in sputum samples [ Time Frame: Day 1, 29, 57 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
Official Title  ICMJEA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).
Brief Summary

This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Condition  ICMJECystic Fibrosis
Intervention  ICMJE
  • Drug: Tobramycin Inhalation Powder
    Tobramycin Inhalation Powder as produced by a modified manufacturing process (TIP new)
  • Drug: Placebo
    Placebo
Study Arms / Comparison Groups
  • TIP new: Experimental
    Tobramycin inhalation powder as produced by a modified manufacturing process
    Intervention: Drug: Tobramycin Inhalation Powder
  • Placebo: Placebo Comparator
    Placebo
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE100
Estimated Completion DateFebruary 2010
Estimated Primary Completion DateFebruary 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of cystic fibrosis patients with Pseudomonas aeruginosa infection.
  • Male and female subjects between 6 and 21 years of age at the time of screening.
  • FEV1 at screening must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

  • Any use of inhaled anti-pseudomonal antibiotics within 4 months prior to screening.
  • Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Other protocol-defined inclusion/exclusion criteria may apply

GenderBoth
Ages6 Years to 21 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis Pharmaceuticals+41 61 324 1111
Location Countries  ICMJEEstonia,   Latvia,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00918957
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECTBM100C2303, EudraCT 2008-002318-22
Study Sponsor  ICMJENovartis Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Novartis PharmaceuticalsNovartis Pharmaceuticals
Information Provided ByNovartis