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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 is a clinical trial that has completed, run by Mylan. The registered enrollment target is 409 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 409 participants |
| Start Date | 2015-05-05 |
| Est. Completion | 2021-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02449031
The ClinicalTrials.gov registry entry for NCT02449031 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 409 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which TOBI® PODHALER® is the first listed.
NCT02449031 reports 0 study locations.
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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