Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Invivodata has announced that its DiaryPRO field-based ePRO system was used to capture primary efficacy endpoint data in the recently unblinded Phase III study of Pollinex Quattro, a vaccine being developed by Allergy Therapeutics to treat the symptoms of seasonal allergic rhinoconjunctivitis.
Subscribe to our email newsletter
Invivodata designed a DiaryPRO solution for over 1,000 international trial subjects to use and over 90 investigative sites to administer. During the trial, investigative sites across the US, Canada and Europe trained patients to use DiaryPRO in their native language. Patients then recorded the daily frequency and severity of allergy symptoms during the entire 2007 grass pollen season.
Data collected with DiaryPRO supported the study’s primary efficacy endpoint, demonstrating that Pollinex Quattro has statistically significant clinical benefits over placebo. Allergy Therapeutics intends to use the results of this Phase III trial to support a marketing authorization application in the EU.
Wolfgang Summa, vice president for Europe and Asia Pacific at Invivodata, said: “We are very proud to have supported the largest controlled allergy vaccine study ever conducted in this patient population, once again demonstrating the value of our ePRO technology in large, international clinical trials.”