Actelion is running a phase four trial called TRACE. Phase four means that the product in question is already on the market. The product name is Selexipag and it was approved for the European market after the largest and longest running trial (GRIPHON) in PAH history. The study was recently presented in the poster section in Orlando, USA at the PHA conference.

 The special about the TRACE study is that Hall Skaara (staff member of PHA Europe and leader of the Norwegian association) is part of the steering committee. This might be the first time a patient holds this position as it previously only has been reserved to health care professionals. However, this is a sign of the time as things in the medical field are getting more and more patient centric.

Hall presented the poster in Orlando. He explained that it is a 26 weeks long study involving 100 patients from potensial 30 sites in USA and Europe. (Ukraine is unfortunately not invited to participate in the study.) The study is ongoing as only 29 patients has been recruited so far.

Half the patients will be given the drug Selexipag (oral prostacyclin), while the other half will be given placebo pills. All patients will also be given a wrist device (looks like a large arm watch) and a computer tablet. The wrist device will show the time and nothing more. However, it will collect a lot of data about the patient. All activity level will be collected plus the sleep pattern. This data will be uploaded to a central site once a day. The computer tablet will be used to fill out a questionnaire three times during the study. The questionnaire has questions related to the patients well being. Do they feel tired, experience chest pains, can they walk up stairs without problems, etc.

The purpose being the study is to check if a person receiving Selexipag will become more physical active than the people receiving placebo. And will the person also experience that his/her condition improves? These endpoints are unusual in PAH studies. Often endpoints are related to six minutes walking distance and to biomarkers (blood tests). However, these patient centric endpoints will probably be more common in future studies as this has been requested by patients association task force during the PAH symposium for the world’s leading PAH specialists that was held earlier this year.

The study will probably run for about two years. Selexipag has, in a previous study, been shown to have a positive health effect on PAH patients. It will be interesting to see if patients on this drug also feel better and becomes more physical active.