NCT00125346|TerminatedPhase 3

Study Stopped

per Data Monitoring Committee recommendation

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

EVOLVE

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

Novartis ClinicalTrials.gov

Compare

1 other identifier

CTBM100C2301

Study Type

interventional

Target

Locations

8 countries

Sites

Timeline

RegisteredAug 2005

StartedSep 2005

CompletionFeb 2007

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Sep 2005

Geographic Reach

8 countries

41 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

July 28, 2005

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed

1 month until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed

Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

1.4 years

First QC Date

July 28, 2005

Last Update Submit

October 10, 2011

Conditions

Cystic Fibrosis

Keywords

Tobramycin Inhalation Powder

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

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,

Interventions

Tobramycin Inhalation PowderDRUG

Eligibility Criteria

Age6 Years - 21 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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.

You may not qualify if:

Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Contact the study team to confirm eligibility.