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

October 10, 2011 updated by: Novartis

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Cordoba, Argentina
        • For information on a site near you, call 1-800-244-7668 Option "2"
  • Brazil
    • PR
      • Curitiba, PR, Brazil
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • SC
      • Florianopolis, SC, Brazil
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • San Paolo
      • Campinas, San Paolo, Brazil
        • For information on a site near you, call 1-800-244-7668 Option "2"
  • Bulgaria
      • Varna, Bulgaria
        • For information on a site near you, call 1-800-244-7668 Option "2"
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Ontario
      • Hamilton, Ontario, Canada
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Quebec
      • Sainte-Foy, Quebec, Canada
        • For information on a site near you, call 1-800-244-7668 Option "2"
  • Chile
      • Santiago, Chile
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Viña del Mar, Chile
        • For information on a site near you, call 1-800-244-7668 Option "2"
  • Lithuania
      • Vilnius, Lithuania
        • For information on a site near you, call 1-800-244-7668 Option "2"
  • Mexico
      • Mexico City, Mexico
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Monterrey, Mexico
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Tijuana, Mexico
        • For information on a site near you, call 1-800-244-7668 Option "2"
  • United States
    • Alabama
      • Mobile, Alabama, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Arizona
      • Phoenix, Arizona, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • California
      • Fresno, California, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Long Beach, California, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Los Angeles, California, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Oakland, California, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Sacramento, California, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Florida
      • Orlando, Florida, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Pensacola, Florida, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Georgia
      • Atlanta, Georgia, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Augusta, Georgia, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Illinois
      • Chicago, Illinois, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Oak Lawn, Illinois, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Michigan
      • Ann Arbor, Michigan, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • New York
      • New Hyde Park, New York, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • New York, New York, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Valhalla, New York, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • North Carolina
      • Durham, North Carolina, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Ohio
      • Cleveland, Ohio, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
      • Columbus, Ohio, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • South Carolina
      • Charleston, South Carolina, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Texas
      • Tyler, Texas, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • Utah
      • Salt Lake City, Utah, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"
    • West Virginia
      • Morgantown, West Virginia, United States
        • For information on a site near you, call 1-800-244-7668 Option "2"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

July 28, 2005

First Submitted That Met QC Criteria

July 28, 2005

First Posted (Estimate)

August 1, 2005

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 10, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTBM100C2301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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