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Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

NCT01519661 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2015-02-10

Study results available
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Summary

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

Conditions

  • Pulmonary Infections
  • Pseudomonas Aeruginosa in Cystic Fibrosis

Interventions

DRUG

TBM100

Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01519661 on ClinicalTrials.gov