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

Completed

Conditions studied: Pseudomonas Aeruginosa in Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02449031

Run by

Mylan Inc.

People needed

409

Starts

2015-05-05

Expected to finish

2021-12-31

Last updated by the study team

2022-03-22

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 6 years of age.
• Documented FEV1 ≥ 25% predicted in the previous year.
• Diagnosis of cystic fibrosis.
• Established diagnosis of chronic P. aeruginosa infection of the lungs defined as two or more positive P. aeruginosa cultures in the previous year as documented in the subject's medical history (this may include a history of one positive culture in the year prior to enrollment and one positive culture from the specimen collected at the baseline visit).
• Prescribed and initiated chronic treatment with FDA-approved inhaled antipseudomonal antibiotic for chronic P. aeruginosa infection (e.g. TOBI® PODHALER®, TOBI®, Cayston® and Bethkis®).
• Actively enrolled or willingness to enroll in PortCF registry.
• Willing and able to provide written informed consent or, parent/guardian consent and where applicable pediatric assent, for participation and use of relevant clinical data previously captured in PortCF.
• Anticipated to have good adherence to routine visits, defined as the investigator having good knowledge that the patient has been to at least 2-3 routine visits in the previous year.

You may not qualify if…

• Documented FEV1 < 25% predicted in the previous year.
• Current participation in an interventional clinical study with an inhaled antibiotic treatment.
• Treatment with compounded tobramycin (e.g. the use of tobramycin IV solution adapted for use by inhalation).
• Treatment with inhaled antipseudomonal antibacterial drug(s) that are not FDA approved.
• Patients undergoing an early eradication regimen for CF (first line therapy).

Where it is running

• Novartis Investigative Site — Anchorage, Alaska, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Bellflower, California, United States
• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Madera, California, United States
• Novartis Investigative Site — Hartford, Connecticut, United States
• Novartis Investigative Site — New Haven, Connecticut, United States
• Novartis Investigative Site — Stamford, Connecticut, United States
• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Boise, Idaho, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Iowa City, Iowa, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Grand Rapids, Michigan, United States
• Novartis Investigative Site — Ypsilanti, Michigan, United States
• Novartis Investigative Site — Jackson, Mississippi, United States
• Novartis Investigative Site — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.