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



Status:Active, not recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:6 - Any
Updated:5/20/2018
Start Date:May 5, 2015
End Date:July 31, 2023

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A Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® Podhaler™ (Tobramycin Inhalation Powder) 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 with inhaled antipseudomonal antibiotics and data over 5 years on
microbiological and safety assessments.

This study will include CF patients chronically colonized with P. aeruginosa enrolled in the
Cystic Fibrosis Foundation (CFF) PortCF registry and using TOBI Podhaler or another
FDA-approved inhaled antipseudomonal antibiotic. No therapeutic intervention will be assigned
and physicians will use their discretion in choosing a treatment regimen for their patients.

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.

Inclusion Criteria:

- ≥ 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.

Exclusion Criteria:

- 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).
We found this trial at
46
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Anchorage, Alaska 99508
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Akron, Ohio 44308
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Atlanta, Georgia 30322
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Atlanta, GA
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Austin, Texas 78759
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Austin, TX
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Bellflower, California 90706
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Billings, Montana 59102
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Boise, Idaho 83712
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Boise, ID
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Boston, Massachusetts 02118
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Boston, MA
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Burlington, Vermont 05401
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Charleston, South Carolina 29407
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Chicago, Illinois 60612
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Chicago, IL
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Dallas, Texas 75216
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Detroit, Michigan 48202
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Fullerton, California 92835
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Fullerton, CA
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Gainesville, Florida 32608
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Grand Rapids, Michigan 49503
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Hartford, Connecticut 06106
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Hershey, Pennsylvania 17033
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Indianapolis, Indiana 46202
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Iowa City, Iowa 52240
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Jackson, Mississippi 39209
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Kansas City, Missouri 64111
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Lebanon, New Hampshire 03756
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Little Rock, Arkansas 72204
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Los Angeles, California 90095
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Madera, California 93637
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Miami, Florida 33136
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Nashville, Tennessee 37205
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New Brunswick, New Jersey 08901
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New Haven, Connecticut
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New Hyde Park, New York 11040
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New Orleans, Louisiana 70115
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Norfolk, Virginia 23507
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Oklahoma City, Oklahoma 73104
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Omaha, Nebraska 68144
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Orlando, Florida 32806
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Philadelphia, Pennsylvania 19102
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Richmond, Virginia 23249
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Salt Lake City, Utah 84103
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Sioux Falls, South Dakota 57104
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Spokane, Washington 99202
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Stamford, Connecticut 06905
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Tampa, Florida 33613
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Tyler, Texas 75701
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Winston-Salem, North Carolina 27157
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Ypsilanti, Michigan 48197
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