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Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

NCT01082367 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-07-15

Study results available
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Summary

This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

Conditions

  • Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients

Interventions

DRUG

TOBI

TOBI (tobramycin inhaled solution)

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
3 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Canada
  • Egypt
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Romania
  • Russia
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT01082367 on ClinicalTrials.gov