search
Back to results

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects (EVOLVE)

Primary Purpose

Cystic Fibrosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tobramycin Inhalation Powder
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Tobramycin Inhalation Powder

Eligibility Criteria

6 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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: Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Sites / Locations

  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"
  • For information on a site near you, call 1-800-244-7668 Option "2"

Outcomes

Primary Outcome Measures

Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5.

Secondary Outcome Measures

Time until first antipseudomonal antibiotic (an antibiotic used to treat bacteria of a certain type [the genus pseudomonas]) is used
Relative changes in FEV1 % predicted for patients who received TIP starting at visit 1 and for patients who received placebo starting at week 9, compared to all subsequent visits.
Relative change in FEV1 % predicted for patients who received placebo from week 5 to week 13
Relative change in FEV1 % predicted for patients who received placebo (from the average of four assessments [weeks 1, 2, 5, and 9] to week 13)
Change from baseline in susceptibility of pseudomonas to the antibiotic during the study measured at weeks 5, 9, 13, 17, 21, and 25, and change from baseline in quantity of pseudomonas found in sputum during the study measured at weeks 5, 9, 13, 17, 21,

Full Information

First Posted
July 28, 2005
Last Updated
October 10, 2011
Sponsor
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT00125346
Brief Title
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects
Acronym
EVOLVE
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Why Stopped
per Data Monitoring Committee recommendation
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Tobramycin Inhalation Powder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tobramycin Inhalation Powder
Primary Outcome Measure Information:
Title
Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5.
Secondary Outcome Measure Information:
Title
Time until first antipseudomonal antibiotic (an antibiotic used to treat bacteria of a certain type [the genus pseudomonas]) is used
Title
Relative changes in FEV1 % predicted for patients who received TIP starting at visit 1 and for patients who received placebo starting at week 9, compared to all subsequent visits.
Title
Relative change in FEV1 % predicted for patients who received placebo from week 5 to week 13
Title
Relative change in FEV1 % predicted for patients who received placebo (from the average of four assessments [weeks 1, 2, 5, and 9] to week 13)
Title
Change from baseline in susceptibility of pseudomonas to the antibiotic during the study measured at weeks 5, 9, 13, 17, 21, and 25, and change from baseline in quantity of pseudomonas found in sputum during the study measured at weeks 5, 9, 13, 17, 21,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Facility Information:
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Fresno
State/Province
California
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Long Beach
State/Province
California
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Los Angeles
State/Province
California
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Oakland
State/Province
California
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Sacramento
State/Province
California
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Orlando
State/Province
Florida
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Oak Lawn
State/Province
Illinois
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
New York
State/Province
New York
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Valhalla
State/Province
New York
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Tyler
State/Province
Texas
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Buenos Aires
Country
Argentina
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Cordoba
Country
Argentina
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Campinas
State/Province
San Paolo
Country
Brazil
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Florianopolis
State/Province
SC
Country
Brazil
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Varna
Country
Bulgaria
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Sainte-Foy
State/Province
Quebec
Country
Canada
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Santiago
Country
Chile
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Viña del Mar
Country
Chile
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Vilnius
Country
Lithuania
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Mexico City
Country
Mexico
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Monterrey
Country
Mexico
Facility Name
For information on a site near you, call 1-800-244-7668 Option "2"
City
Tijuana
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

We'll reach out to this number within 24 hrs