Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With CF



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:1/12/2019
Start Date:October 21, 2016
End Date:March 31, 2020
Contact:David P Nichols, MD
Phone:303-398-1876

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TEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A Randomized, Placebo-controlled, Double-blinded Trial of Azithromycin 500mg Thrice Weekly in Combination With Inhaled Tobramycin

This is a study to examine the effect of combining chronic oral azithromycin with inhaled
tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected
with P. aeruginosa.

This study is a prospective, randomized, double-blinded, placebo-controlled trial of
azithromycin 500mg taken orally thrice weekly vs. placebo in subjects with cystic fibrosis
and chronic airway infection with P. aeruginosa who are utilizing chronic inhaled tobramycin
therapy. It will include approximately 120 subjects able to complete a primary 6-week study
phase. Subjects will be at least 12 years old with a baseline FEV1 between 25-100% predicted.
Subjects will continue to use clinically prescribed inhaled tobramycin cycled on/off every 4
weeks. They will be provided over-encapsulated azithromycin 500mg tablets or placebo during
the primary study phase. An optional extension phase will be offered to all subjects
completing the primary 6-week study. This 8-week extension phase will include an initial 4
weeks without use of inhaled tobramycin or other inhaled antibiotics, followed by a 4-week
period with inhaled tobramycin use. All subjects participating in the extension phase of the
study will be provided azithromycin 500mg tablets to be taken thrice weekly for the entire
8-week period.

This study will investigate how use of chronic oral azithromycin affects some of the
previously demonstrated benefits to health when using inhaled tobramycin. The primary
measurements will focus on lung function. Additional measurements will focus on
disease-related quality of life as reported by subjects in the trial. Exploratory outcomes,
including measurements of safety, are also planned.

Inclusion Criteria:

- 12 years old or older

- documented diagnosis of cystic fibrosis

- written informed consent (and assent when applicable)

- at least two respiratory cultures growing P. aeruginosa within the last 12 months

- FEV1% predicted between 25-100%

- use of at least two cycles of inhaled tobramycin within the last 24 weeks

- Off TISP and other inhaled anti-pseudomonal antibiotics for at least 2 weeks at Visit
1 and remain off of any inhaled antibiotics for an additional 2 weeks before starting
inhaled tobramycin

- most recent liver function test results less than 4 times the upper limit of normal,
obtained within the last 12 months

- prior or current use of azithromycin for at least four consecutive weeks

- stable clinical status and therapeutic regimen

Exclusion Criteria:

- weight <40 kg

- positive pregnancy test, lactating, or unwillingness to practice a pre-defined form of
contraception, which includes abstinence

- inability to perform reproducible spirometry

- inability or unwillingness to cycle off of inhaled tobramycin for one 4-week period
and without use of any additional inhaled antibiotics

- respiratory culture with Burkholderia cepacia complex species within 24 months or with
nontuberculous mycobacteria within 18 months of screening

- use of intravenous or oral anti-pseudomonal antibiotics within 4 weeks of screening

- use of investigational therapy within 4 weeks of screening

- use of systemic corticosteroids equivalent to a daily dose more than 10mg of
prednisone

- use of nelfinavir, warfarin, haloperidol, or methadone (concern of drug interaction
with azithromycin)

- initiation of CFTR modulator therapy within 30 days

- ECG abnormality at screening requiring prompt further medical attention, or QTc
interval >480 msec for males and >486 msec for females

- any other condition that, in the opinion of the site investigator, would compromise
the safety of the subject or quality of the data
We found this trial at
39
sites
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Jerry Nick, MD
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Peter Mogayzel, MD, PhD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: George Retsch-Bogart, FAAP, MD
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Gary McPhail, MD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Jorge Lascano, MD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Thomas Keens, MD
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Principal Investigator: Patricia Walker, MD
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Principal Investigator: Floyd Livingston, MD
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Principal Investigator: Okan Elidemir, MD
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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Philadelphia, Pennsylvania 19134
Principal Investigator: Laurie Varlotta, MD
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Joseph Pilewski, MD
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Lindsay Lindsay Caverly, MD
University of Michigan Health System The University of Michigan is home to one of the...
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Boise, Idaho 83712
Principal Investigator: Perry Brown, MD
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Greg Sawicki, MD
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Manu Jain, MD
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Cleveland, Ohio 44115
Principal Investigator: Seth Walker, MD
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Dayton, Ohio 45404
Principal Investigator: Gary Mueller, FCC, MD
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Karen Schultz, MD
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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Grand Rapids, Michigan 49503
Principal Investigator: Susan Millard, MD
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500 University Drive
Hershey, Pennsylvania 17033
Principal Investigator: Gavin Graff, MD
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Clement Ren, MD, MMM
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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2401 Gillham Road
Kansas City, Missouri 64108
Principal Investigator: Hugo Escobar, MD
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Long Branch, New Jersey
Principal Investigator: Robert Zanni, CPI, MD
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Nicholas Antos, MD
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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516 Delaware Street Southeast
Minneapolis, Minnesota 55455
Principal Investigator: Sarah Schwarzenberg, MD
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Marie Egan, MD
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10032
Principal Investigator: Hossein Sadeghi, MD
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Palo Alto, California 94304
Principal Investigator: Carlos Milla, MD
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Peoria, Illinois 61637
Principal Investigator: Subramanyan Chittivelu, MD
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Portland, Maine 04102
Principal Investigator: AnneMarie Cairns, DO
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Portland, Oregon 97227
Principal Investigator: Kelvin MacDonald, MD
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Rochester, New York 14642
Principal Investigator: Karen Voter, MD
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Saint Louis, Missouri 63104
Principal Investigator: Gary Albers, MD
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Saint Louis, Missouri 63110
Principal Investigator: Jessica Pittman, MD, MPH
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26 1900 East
Salt Lake City, Utah 84113
Principal Investigator: Fadi Asfour, MD
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San Diego, California 92123
Principal Investigator: Douglas Conrad, MD
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Ron Gibson, MD, PhD
Phone: 206-987-1427
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Christopher Goss, MD
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Worcester, Massachusetts 01605
Principal Investigator: Ted Kremer, MD
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