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Trial record 1 of 4 for:    azithromycin tobramycin CF
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Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With CF (TEACH)

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ClinicalTrials.gov Identifier: NCT02677701
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
CF Therapeutics Development Network Coordinating Center
Information provided by (Responsible Party):
David Nichols, MD, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: azithromycin Drug: placebo (for azithromycin) Drug: inhaled tobramycin Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 21, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020


Arm Intervention/treatment
Active Comparator: azithromycin
azithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks
Drug: azithromycin
500mg tablet over-encapsulated to match placebo
Other Name: Zithromax

Drug: inhaled tobramycin
clinically prescribed inhaled tobramycin used by subjects participating in the study

Placebo Comparator: placebo
encapsulated placebo taken by mouth thrice weekly for 6 weeks
Drug: placebo (for azithromycin)
Drug: inhaled tobramycin
clinically prescribed inhaled tobramycin used by subjects participating in the study




Primary Outcome Measures :
  1. relative change in lung function [ Time Frame: baseline (week 0) to week 6 (6 week period) ]
    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


Secondary Outcome Measures :
  1. relative change in lung function [ Time Frame: week 2 to week 6 (4 week period) ]
    Relative change in FEV1 (L) from the beginning of the 4-week period with inhaled tobramycin at week 2 to the end of the 4-week period with inhaled tobramycin at week 6



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677701


Contacts
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Contact: David P Nichols, MD 303-398-1876
Contact: Shannon Kirby 206-884-1484

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Sponsors and Collaborators
Seattle Children's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
CF Therapeutics Development Network Coordinating Center
Investigators
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Principal Investigator: David P Nichols, MD National Jewish Health

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Responsible Party: David Nichols, MD, Associate Professor of Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02677701     History of Changes
Other Study ID Numbers: TEACH-IP-15
1R01HL124053-01A1 ( U.S. NIH Grant/Contract )
NICHOL15A0 ( Other Grant/Funding Number: Cystic Fibrosis Foundation Therapeutics )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents