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Second Open Label Extension to Bridging Study CTBM100C2303

NCT01069705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-06-02

Study results available
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Summary

This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.

Conditions

  • Pulmonary Infections
  • Pseudomonas Aeruginosa

Interventions

DRUG

Tobramycin inhalation powder

Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-12
Primary Completion
2012-03-19
Completion
2012-03-19
FDA Drug
Yes

Countries

  • Bulgaria
  • Estonia
  • Latvia
  • Lithuania
  • Romania
  • Russia
  • South Africa

Study Locations

More Related Trials

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 NCT01069705 on ClinicalTrials.gov