Impact of Combination Therapy on Cystic Fibrosis (TEACH Study)

Trial Objective

The purpose of this study is to determine how two medications, azithromycin and inhaled tobramycin, work when taken together to treat cystic fibrosis (CF) patients with chronic pseudomonas aeruginosa (PA) lung infections. Some data suggest that azithromycin and inhaled tobramycin do not work well when used together. Our researchers want to determine if taking azithromycin with inhaled tobramycin has a negative impact on how well people with CF breathe. They also want to determine if the combination of medications improves or worsens the health of people with CF.


Azithromycin is approved by the Food and Drug Administration (FDA) for treatment of certain types of infections, such as ear infections, and some types of pneumonia in adults and children older than 6 months of age. Since the FDA has not approved azithromycin for treatment of CF, it is considered an investigational drug in this study. Inhaled tobramycin, an antibiotic, is inhaled as either a solution or dry powder. The FDA has approved it for CF patients age 6 and older with a PA infection. Some study participants will receive a placebo (an inactive substance) instead of azithromycin.

Enrollment

This trial is active and currently recruiting.

How to Participate

For more information, call 303.398.1808 or complete the form below.

Who Can Participate

Cystic fibrosis patients who are age 12 or older who have had a pseudomonas aeruginosa (PA) infection in the past year and have taken inhaled tobramycin in the last six months may be eligible to participate.


Estimated Time Commitment

3 visits over 6 weeks totaling up to 7 hours

The first part involves three visits over 6 weeks and takes up to seven hours. Participants who complete all study visits in the first part will have the option to remain in the study for another eight weeks. The second part of the study will not have a placebo group; all participants will receive azithromycin.

Trial Location

National Jewish Main Campus, Denver, CO

Compensation

Provided

Trial Sponsors

National Institutes of Health (NIH) and the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT)

Age

12+


Gender

Any Gender

Principal Investigators


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