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.
To hear more about how Spinnaker helps with the NovelSTART Trial, read the case study or get in touch.