The NovelSTART trial is a randomised controlled study of combined reliever/preventer medication for intermittent or mild asthma. It is a 52-week, open label, parallel group study operating 24/7 in sites in New Zealand, Australia, Britain, and Italy. To date there are 15 different research institutions involved – a combination of hospitals, independent private medical research institutes, and private “for profit” research institutes.
The NovelSTART Trial
People with persistent intermittent or mild asthma often use a reliever inhaler like Ventolin. They may also use a preventer (such as Flixotide) to control symptoms. Researchers, physicians, the pharmaceutical industry and guideline authors have been looking for many years for a better ‘real world’ treatment that makes it easier for the patient to use and that is effective. The Novel START trial will help to answer the question of whether a combined therapy is safe and effective for the treatment of mild asthma.
During the study 675 adult participants will be randomly allocated to receive one of 3 regimens, one of which is a combined therapy.
Robust system needed for global study
This trial was Spirals first venture into clinical trials outside of the hospital environment. This meant we needed to structure the work-flow in Spinnaker slightly differently and aim for even greater ease of use.
The collection of data and the entry of data, in a hospital based study, can be more seperate, or delayed if there is any glitch in the system. With a community based trial, like NovelSTART, participants visit their medical centre and the clinician/investigator collects and reviews critical data on the spot before the participant leaves the appointment. This means there is extra pressure on Spinnaker to perform at the highest levels. The robust nature of Spinnaker means we can meet these demands for any country, any time.
Spinnaker integrates with other software
Spinnaker’s bespoke nature means we can tailor, extend and integrate the software for your individual trial.
NovelSTART uses cutting edge Smartinhalers supplied by Adherium to collect every activation of an inhaler. This data is transmitted to Adherium’s SmartinhalerLive system. Spinnaker then interrogates that data to provide the investigator with an immediate update on inhaler actuations during a participants visit to the centre.
“The ability to accurately monitor patients’ medication use and ensure that the study data is captured objectively and accurately is incredibly useful” said MRINZ Director Richard Beasley.
“Fantastic… We’re really impressed with what Spiral is able to do in a short time, and when issues arise, they are dealt with asap.
The Spinnaker system has been completely stable with no downtime issues. It handles randomisation very well and we need it to be operating 24/7 in all time zones, as patients can visit any of our sites at any time.”
Mark Holliday, Clinical Trials Manager, The Medical Research Institute of New Zealand
NovelSTART Software Case Study
Read what people are saying about the NovelSTART Trial on Twitter
Read what people are saying about the NovelSTART Trial on Twitter.