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NCT02449031 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Mylan.

Completed
Registry status
409
Enrollment target

NCT02449031: Completed study, sponsored by Mylan.

NCT02449031 is a clinical trial that has completed, run by Mylan. The registered enrollment target is 409 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02449031 has completed, sponsored by Mylan.

COMPLETED
Registry status
409 participants
Enrollment target

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.

Interventions

  • DRUG TOBI® PODHALER®
  • DRUG TOBI®
  • DRUG Bethkis®
  • DRUG Cayston®

Trial Details

FieldValue
Enrollment Target 409 participants
Start Date 2015-05-05
Est. Completion 2021-12-31
Mylan

22 total trials

What the finished NCT02449031 record still lists

NCT02449031 is an observational study that tracks outcomes without assigning an intervention. The registered 409 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 4 interventions - of which TOBI® PODHALER® is the first listed.

NCT02449031 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02449031 about?

NCT02449031 is a clinical study titled "Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs". 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 wit...

What is the current status of trial NCT02449031?

This trial is currently completed. The enrollment target is 409 participants. The study started on 2015-05-05. Estimated completion is 2021-12-31.

What interventions are being tested in trial NCT02449031?

The interventions under investigation include: TOBI® PODHALER® (DRUG), TOBI® (DRUG), Bethkis® (DRUG), Cayston® (DRUG).

Who is sponsoring clinical trial NCT02449031?

This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02449031, the US trial registry maintained by the National Library of Medicine. NCT02449031 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.