Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)
TEACH
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
3 other identifiers
interventional
119
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2016
Typical duration for phase_4
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2016
CompletedFirst Posted
Study publicly available on registry
February 9, 2016
CompletedStudy Start
First participant enrolled
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2020
CompletedResults Posted
Study results publicly available
March 1, 2021
CompletedJune 28, 2021
June 1, 2021
3.3 years
January 29, 2016
February 9, 2021
June 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Relative Change in Lung Function
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
baseline (week 0) to week 6 (6 week period)
Secondary Outcomes (3)
Relative Change in Lung Function
week 2 to week 6 (4 week period)
Change in Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)
baseline (week 0) to week 6 (6 week period)
Change in Cystic Fibrosis Questionnaire - Revised Respiratory Symptom Score (CFQ-R RSS)
baseline (week 0) to week 6 (6 week period)
Other Outcomes (1)
Change in Sputum Pseudomonas Aeruginosa Bacterial Density
baseline (week 0) to week 6 (6 week period)
Study Arms (2)
azithromycin
ACTIVE COMPARATORazithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks
placebo
PLACEBO COMPARATORencapsulated placebo taken by mouth thrice weekly for 6 weeks
Interventions
clinically prescribed inhaled tobramycin used by subjects participating in the study
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 cystic fibrosis transmembrane conductance regulator (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Cystic Fibrosis Foundationcollaborator
- CF Therapeutics Development Network Coordinating Centercollaborator
Study Sites (39)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Stanford University Medical Center
Palo Alto, California, 94025, United States
Rady Children's Hospital and Health Center at the University of California San Diego
San Diego, California, 92123, United States
National Jewish Health
Denver, Colorado, 80206, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
University of Florida
Gainesville, Florida, 32610, United States
The Nemours Children's Clinic - Orlando
Orlando, Florida, 32806, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504, United States
Saint Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, 83712, United States
Northwestern University
Chicago, Illinois, 60208, United States
Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Maine Medical Partners Pediatric Specialty Care
Portland, Maine, 04102, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01655, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55455, United States
Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Children's Hospital of New York
New York, New York, 10032, United States
University of Rochester Medical Center Strong Memorial
Rochester, New York, 14642, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, 17033, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Intermountain Cystic Fibrosis Center
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98145, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Arthur Baines
- Organization
- Seattle Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
David P Nichols, MD
National Jewish Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
January 29, 2016
First Posted
February 9, 2016
Study Start
October 21, 2016
Primary Completion
February 13, 2020
Study Completion
February 13, 2020
Last Updated
June 28, 2021
Results First Posted
March 1, 2021
Record last verified: 2021-06