Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs
NCT ID: NCT02449031
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
409 participants
OBSERVATIONAL
2015-05-05
2021-12-31
Brief Summary
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Detailed Description
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Sputum samples (primarily collected during routine clinical follow-up) from patients able to spontaneously produce sputum will be sent to a central laboratory for analysis.
In addition, this study will include two optional sub-studies for qualifying patients in the first study year - Sputum microbiology sub-study and TOBI® PODHALER® sputum pharmacokinetics (PK) sub-study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TOBI® PODHALER® cohort
TOBI® PODHALER®
non-TOBI® PODHALER® cohort
Approximately 250 patients treated with other FDA-approved inhaled antipseudomonal antibacterial drugs at enrollment
TOBI®
tobramycin inhalation solution, USP
Bethkis®
tobramycin inhalation solution
Cayston®
aztreonam for inhalation solution
Interventions
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TOBI® PODHALER®
TOBI®
tobramycin inhalation solution, USP
Bethkis®
tobramycin inhalation solution
Cayston®
aztreonam for inhalation solution
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
6 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Mylan Inc.
INDUSTRY
Responsible Party
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Locations
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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
Novartis Investigative Site
Billings, Montana, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Lebanon, New Hampshire, United States
Novartis Investigative Site
New Brunswick, New Jersey, United States
Novartis Investigative Site
New Hyde Park, New York, United States
Novartis Investigative Site
Winston-Salem, North Carolina, United States
Novartis Investigative Site
Akron, Ohio, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Hershey, Pennsylvania, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Charleston, South Carolina, United States
Novartis Investigative Site
Sioux Falls, South Dakota, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Austin, Texas, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Tyler, Texas, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
Burlington, Vermont, United States
Novartis Investigative Site
Norfolk, Virginia, United States
Novartis Investigative Site
Richmond, Virginia, United States
Novartis Investigative Site
Spokane, Washington, United States
Countries
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Other Identifiers
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CTBM100C2407
Identifier Type: -
Identifier Source: org_study_id
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