EPIC Trials are Ongoing at Riley

by Mary Blagburn, BSN, RN

The Riley Hospital Cystic Fibrosis Center is participating in two Cystic Fibrosis Foundation (CFF) sponsored trials regarding early intervention with Pseudomonas aeruginosa. The first trial is strictly observational. We have enrolled children up to age 12 who have never grown Pseudomonas before or have been negative for Pseudomonas for a 2 year period. We then just observe them for this project. What this means is that each time a child is in clinic a few additional questions will be asked of them by the clinic staff as a part of their interview. Once a year a small amount of blood will be collected with the annual screening labs, and once a year a questionnaire will be completed. If a child who is enrolled in the observational study should begin to grow Pseudomonas they would then be invited to join in our Clinical portion of EPIC. Even if your child (who is less than 12) is not enrolled in the observational portion of the study but cultures positive for Pseudomonas they may be eligible for the EPIC Clinical.

The EPIC Clinical is designed to determine the best way to treat persons who have a first time growth of Pseudomonas aerations. The EPIC Clinical is evaluating the use of TOBI from every other month to every third month. Some of those involved will receive the oral antibiotic Ciprofloxacin (Cipro), and some will receive a placebo (no medication in the pill or liquid). This part of the trial is being done to look at the effect of Cipro in treating Pseudomonas. Participants will be placed in two categories once they qualify: Culture based or Cycle base therapy. Those on cycle base will automatically receive TOBI and Cipro study drug every 3 months when they are seen in clinic. Those on culture base will only receive the medications every 3 months if they are positive for Pseudomonas.

New TOBI Formulation

Our center is also participating in testing the new dry powder inhaled formulation of TOBI. It is referred to as TIP or TOBI Inhaled Powder. We participated in an early small phase 1 study here at Riley and the new formulation was well tolerated and had good patient satisfaction. This trial will allow participants to receive either the TIP or currently approved TOBI during their participation. Participants are assigned either form by a computerized randomization system once they qualify for the study. This means that neither study participants nor those helping with the study get to pick the form of TOBI they receive. The medication is provided at no cost to everyone involved in the study.