July and August 2015 Clinical Trials

The CF Foundation recently provided an update on the following three research trials.

07/01/15 – TOBI Podhaler Observational Study

This is a phase 4 observational trial. It will look at the effectiveness and long term safety of TOBI Podhaler and other FDA approved antipseudomonal drugs.

Researchers will be looking to see if TOBI Podhaler leads to improvement in lung function and a reduction in pseudomonas aeruginosa.

This trial is for people with cystic fibrosis who are ages 6 and older and have a chronic pseudomonas aeruginosa infection. It will last approximately 5 years. Participants will be required to do lung function tests and sputum cultures.

07/17/15 – Study of Liprotamase in people with CF who are 7 years of age or older

This Phase 3, multi-center trial will look at the safety and effectiveness of Liprotamase a new type of digestive enzyme in individuals with CF who have pancreatic insufficiency. Liprotamse is a water-soluble powder made up of three digestive enzymes: lipase, protease and amylase.

Researchers will test the drug’s effectiveness by measuring fat absorption. The goal of the study is to show that Liprotamase works as well or better than currently approved pancreatic enzymes. This trial is for people ages 7 years and older who are currently taking pancreatic digestive enzymes for pancreatic insufficiency. The trial will last approximately 6 months.

08/25/15 – Phase 2 trial of JBT-101 in people with CF

This is a phase 2 placebo controlled trial. It will look at the safety and effectiveness of the anti-inflammatory drug JBT-101 (Resunab).

Researchers aim to show the effectiveness and safety of JBT-101 by showing a reduction in adverse events and improvement in lung function. They will also look at how the body processes the drug. This trial is for people with CF ages 18 to 65. It will require blood tests, lung function tests, and sputum samples.