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Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs

NCT02449031 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 409

Last updated 2022-03-22

No results posted yet for this study

Summary

This is a multicenter, prospective, two cohort, observational study over a 5-year period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on microbiological and safety assessments.

Conditions

  • Pseudomonas Aeruginosa in Cystic Fibrosis

Interventions

DRUG

TOBI® PODHALER®

DRUG

TOBI®

tobramycin inhalation solution, USP

DRUG

Bethkis®

tobramycin inhalation solution

DRUG

Cayston®

aztreonam for inhalation solution

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Mylan Inc.

    lead INDUSTRY

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-05
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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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 NCT02449031 on ClinicalTrials.gov