Summary

for people ages 12 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Douglas Conrad

Description

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.

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

Details

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.

Keywords

Cystic Fibrosis Tobramycin azithromycin inhaled tobramycin

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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 CAN'T join 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 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

Locations

  • Rady Children's Hospital and Health Center at the University of California San Diego not yet accepting patients
    San Diego California 92123 United States
  • Children's Hospital of Los Angeles accepting new patients
    Los Angeles California 90027 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seattle Children's Hospital
ID
NCT02677701
Phase
Phase 4
Lead Scientist
Douglas Conrad
Study Type
Interventional
Last Updated
October 8, 2018