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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02677701
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
CF Therapeutics Development Network Coordinating Center
Information provided by (Responsible Party):
David Nichols, MD, Seattle Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: azithromycin Drug: placebo (for azithromycin) Drug: inhaled tobramycin Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 21, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020


Arm Intervention/treatment
Active Comparator: azithromycin
azithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks
Drug: azithromycin
500mg tablet over-encapsulated to match placebo
Other Name: Zithromax

Drug: inhaled tobramycin
clinically prescribed inhaled tobramycin used by subjects participating in the study

Placebo Comparator: placebo
encapsulated placebo taken by mouth thrice weekly for 6 weeks
Drug: placebo (for azithromycin)
Drug: inhaled tobramycin
clinically prescribed inhaled tobramycin used by subjects participating in the study




Primary Outcome Measures :
  1. relative change in lung function [ Time Frame: baseline (week 0) to week 6 (6 week period) ]
    Relative change in FEV1 volume (L) from enrollment at week 0 to the end of the 4-week period with inhaled tobramycin at week 6


Secondary Outcome Measures :
  1. relative change in lung function [ Time Frame: week 2 to week 6 (4 week period) ]
    Relative change in FEV1 (L) from the beginning of the 4-week period with inhaled tobramycin at week 2 to the end of the 4-week period with inhaled tobramycin at week 6



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677701


Contacts
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Contact: David P Nichols, MD 303-398-1876
Contact: Shannon Kirby 206-884-1484

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Locations
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United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Elizabeth Rowan       erowan@chla.usc.edu   
Principal Investigator: Thomas Keens, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94025
Contact: Colleen Dunn       cedunn@stanford.edu   
Principal Investigator: Carlos Milla, MD         
Rady Children's Hospital and Health Center at the University of California San Diego Not yet recruiting
San Diego, California, United States, 92123
Contact: Karl Perez       kap018@ucsd.edu   
Principal Investigator: Douglas Conrad, MD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Connie St. Clair       stclairc@njhealth.org   
Principal Investigator: Jerry Nick, MD         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Catalina Guzman       catalina.guzman@yale.edu   
Principal Investigator: Marie Egan, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Noni A Graham,       Noni.graham@medicine.ufl.edu   
Principal Investigator: Jorge Lascano, MD         
The Nemours Children's Clinic - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Amanda Darling       amanda.darling@nemours.org   
Principal Investigator: Floyd Livingston, MD         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Rebecca Davis       rebecca.davis@nemours.org   
Principal Investigator: Okan Elidemir, MD         
United States, Idaho
Saint Luke's Cystic Fibrosis Center of Idaho Recruiting
Boise, Idaho, United States, 83712
Contact: Dixie L Durham       durhamd@slhs.org   
Principal Investigator: Perry Brown, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
Contact: Rachel Nelson       rachel.nelson@northwestern.edu   
Principal Investigator: Manu Jain, MD         
Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Ashley Scott       Ashley.Scott@osfhealthcare.org   
Principal Investigator: Subramanyan Chittivelu, MD         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lisa Bendy       lbendy@iupui.edu   
Principal Investigator: Clement Ren, MD, MMM         
United States, Maine
Maine Medical Partners Pediatric Specialty Care Recruiting
Portland, Maine, United States, 04102
Contact: Carrie Milliard       millic@mmc.org   
Principal Investigator: AnneMarie Cairns, DO         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Britany Zeglin       bzeglin1@jhmi.edu   
Principal Investigator: Peter Mogayzel, MD, PhD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Robert Fowler       Robert.fowler@childrens.harvard.edu   
Principal Investigator: Greg Sawicki, MD         
University of Massachusetts Memorial Health Care Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Karen Longtine       karen.longtine@umassmed.edu   
Principal Investigator: Ted Kremer, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Dawn Kruse       dmkruse@med.umich.edu   
Principal Investigator: Lindsay Lindsay Caverly, MD         
Helen DeVos Children's Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Cynthia Gile       cynthia.gile@spectrumhealth.org   
Principal Investigator: Susan Millard, MD         
United States, Minnesota
The Minnesota Cystic Fibrosis Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Minnesota CF Center Participant Contact       cftrials@umn.edu   
Principal Investigator: Sarah Schwarzenberg, MD         
United States, Missouri
Children's Mercy Kansas City Recruiting
Kansas City, Missouri, United States, 64108
Contact: Candy Schmoll       cschmoll@cmh.edu   
Principal Investigator: Hugo Escobar, MD         
Cardinal Glennon Children's Medical Center Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Freda Branch       freda.branch@health.slu.edu   
Principal Investigator: Gary Albers, MD         
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Tina Hicks       hickst@wustl.edu   
Principal Investigator: Jessica Pittman, MD, MPH         
United States, New Jersey
Monmouth Medical Center Recruiting
Long Branch, New Jersey, United States, 07740
Contact: Bridget Marra       bridget.marra@RWJBH.org   
Principal Investigator: Robert Zanni, CPI, MD         
United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Anne Kukral       anne.kukral@mountsinai.org   
Principal Investigator: Patricia Walker, MD         
Children's Hospital of New York Recruiting
New York, New York, United States, 10032
Contact: Hossein Sadeghi       hs762@cumc.columbia.edu   
Principal Investigator: Hossein Sadeghi, MD         
University of Rochester Medical Center Strong Memorial Recruiting
Rochester, New York, United States, 14642
Contact: Barb Johnson       Barbara_Johnson@URMC.Rochester.edu   
Principal Investigator: Karen Voter, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Carol Barlow       cbarlow@med.unc.edu   
Principal Investigator: George Retsch-Bogart, FAAP, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kelly Thornton       Kelly.Thornton@cchmc.org   
Principal Investigator: Gary McPhail, MD         
University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kathleen Hilliard       kathleen.hilliard@uhhospitals.org   
Principal Investigator: Seth Walker, MD         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Sandy Bartosik       bartosiks@childrensdayton.org   
Principal Investigator: Gary Mueller, FCC, MD         
United States, Oregon
Oregon Health Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Brendan Klein       kleinb@ohsu.edu   
Principal Investigator: Kelvin MacDonald, MD         
United States, Pennsylvania
Hershey Medical Center Pennsylvania State University Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Diane Kitch       dkitch@pennstatehealth.psu.edu   
Principal Investigator: Gavin Graff, MD         
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Bianca Ferreira       bf349@drexel.edu   
Principal Investigator: Laurie Varlotta, MD         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Elizabeth Hartigan       elizabeth.hartigan@chp.edu   
Principal Investigator: Joseph Pilewski, MD         
United States, Texas
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Heather Urbanek       Heather.Urbanek@cookchildrens.org   
Principal Investigator: Karen Schultz, MD         
United States, Utah
Intermountain Cystic Fibrosis Center Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Jane B Vroom       jane.vroom@hsc.utah.edu   
Principal Investigator: Fadi Asfour, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98145
Contact: Sharon McNamara, RN    206-987-1427    sharon.mcnamara@seattlechildrens.org   
Principal Investigator: Ron Gibson, MD, PhD         
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Teresa Gambol       TGambol@medicine.washington.edu   
Principal Investigator: Christopher Goss, MD         
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Theresa Kump       tkump@mcw.edu   
Principal Investigator: Nicholas Antos, MD         
Sponsors and Collaborators
Seattle Children's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
CF Therapeutics Development Network Coordinating Center
Investigators
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Principal Investigator: David P Nichols, MD National Jewish Health

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Responsible Party: David Nichols, MD, Associate Professor of Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02677701     History of Changes
Other Study ID Numbers: TEACH-IP-15
1R01HL124053-01A1 ( U.S. NIH Grant/Contract )
NICHOL15A0 ( Other Grant/Funding Number: Cystic Fibrosis Foundation Therapeutics )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents