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

• Status: Completed
• Trial end date: 2020-02-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Children's Hospital
• Collaborators: CF Therapeutics Development Network Coordinating Center; Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Azithromycin; Tobramycin

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 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