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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02677701
• Date of registration: 29/01/2016
• Prospective Registration: Yes
• Primary sponsor: Seattle Children's Hospital
• Public title: Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF) TEACH
• Scientific 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
• Date of first enrolment: October 21, 2016
• Target sample size: 119
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02677701
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: David P Nichols, MD
• Affiliation: National Jewish Health

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: inhaled tobramycin

Drug: placebo (for azithromycin)

Drug: azithromycin

Primary Outcome(s)

relative change in lung function [Time Frame: baseline (week 0) to week 6 (6 week period)]

Secondary Outcome(s)

relative change in lung function [Time Frame: week 2 to week 6 (4 week period)]

Secondary ID(s)

NICHOL15A0

TEACH-IP-15

1R01HL124053-01A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation

CF Therapeutics Development Network Coordinating Center

National Heart, Lung, and Blood Institute (NHLBI)