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

Completed · Phase 4 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02677701

Run by

Seattle Children's Hospital

People needed

119

Starts

2016-10-21

Expected to finish

2020-02-13

Last updated by the study team

2021-06-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Rady Children's Hospital and Health Center at the University of California San Diego — San Diego, California, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• The Nemours Children's Clinic - Orlando — Orlando, Florida, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• Saint Luke's Cystic Fibrosis Center of Idaho — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Saint Francis Medical Center — Peoria, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Maine Medical Partners Pediatric Specialty Care — Portland, Maine, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Massachusetts Memorial Health Care — Worcester, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
• The Minnesota Cystic Fibrosis Center — Minneapolis, Minnesota, United States
• Children's Mercy Kansas City — Kansas City, Missouri, United States
• Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Monmouth Medical Center — Long Branch, New Jersey, United States
• Beth Israel Medical Center — New York, New York, United States
• Children's Hospital of New York — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.