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NCT00388505 · ClinicalTrials.gov registry record · Phase 3

Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

A Phase 3 study of Cystic Fibrosis, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
517
Enrollment target
20
Study locations

NCT00388505 is a Phase 3 study of Cystic Fibrosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 517 participants, above the 176-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (194% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT00388505, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
517 participants
Enrollment target
20
Study locations

Study Summary

This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

Conditions Studied

Interventions

  • DRUG Tobramycin Inhalation Powder
  • DRUG Tobramycin Solution for Inhalation

Study Locations (20)

New York

  • Novartis Investigative Site - Albany
  • Novartis Investigative Site - Buffalo
  • Novartis Investigative Site - New Hyde Park
  • Novartis Investigative Site - New York
  • University of Rochester - Rochester
  • Novartis Investigative Site - Stony Brook
  • Novartis Investigative Site - Syracuse
  • Novartis Investigative Site - Valhalla

New Jersey

  • Novartis Investigative Site - Livingston
  • Novartis Investigative Site - Long Branch
  • Novartis Investigative Site - Morristown
  • Novartis Investigative Site - Somerset

Pennsylvania

  • Penn State College of Medicine - Hershey
  • Drexel University College of Medicine - Philadelphia

Connecticut

  • Novartis Investigative Site - Hartford

Georgia

  • Emory University CF Center - Atlanta

Illinois

  • Rush University Center - Chicago

Kentucky

  • University of Louisville - Louisville

Massachusetts

  • Novartis Investigative Site - Boston

Trial Details

FieldValue
Enrollment Target 517 participants
Start Date 2006-02
Est. Completion 2009-03
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00388505

The ClinicalTrials.gov registry entry for NCT00388505 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 517 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 176-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (194% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Tobramycin Inhalation Powder is the first listed.

NCT00388505 reports 20 study locations spanning 9 distinct geographic areas - top geographies include New York, New Jersey, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00388505 about?

NCT00388505 is a clinical study titled "Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis". This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

What is the current status of trial NCT00388505?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 517 participants. The study started on 2006-02. Estimated completion is 2009-03.

What conditions does trial NCT00388505 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT00388505?

The interventions under investigation include: Tobramycin Inhalation Powder (DRUG), Tobramycin Solution for Inhalation (DRUG).

Who is sponsoring clinical trial NCT00388505?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00388505 being conducted?

This trial has 20 study locations across Connecticut, Georgia, Illinois, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.