RESUMO
This study investigated multiparticulate formulation administered over a two-week period of time via the Sympfiny® system with children of ages 1-12 years. The study was conducted with parent-child pairs (N = 120 total participants) following a specific dose strategy to mimic PURIXAN's dosing guidelines based upon the child's age. PURIXAN® (mercaptopurine) and Methotrexate have been identified as potential chemotherapy drugs that could benefit from reformulation into multiparticulate. Multiparticulate drugs have advantages as they can be flavorless, and do not require liquid reconstitution and do not require refrigeration. The study included three parts: initial in-person session, 14 days of at-home use, and a final in-person session. The in-person sessions were conducted at HS Design's (HSD) (Morristown, NJ, USA) offices located in Morristown, New Jersey, where a study moderator captured and recorded all subjective comments by participants and observed device use to identify use errors. The participants were instructed to administer a dose (placebo) for the next 14 days and at each dose delivery to fill out a daily survey regarding their experience. Overall, the cumulative survey responses and feedback collected during the in-person sessions suggest that child participants ages 5-12 years old found multiparticulate to be an acceptable formulation and would be willing to take this medication if they were sick. Over time, more children ages 1-4 did not open their mouths; consistently around 15-20% of 1-4 years olds spat the placebo. However, approximately 95% of parents found the Sympfiny® system acceptable and indicated that they would use it to deliver medication to their child.
RESUMO
This study demonstrates that students in kindergarten through eighth grade can use the XpressCollect nasal swab to self-collect a specimen under the guidance of a teacher. This phased study was conducted with parents, teachers, and students. Phases 1 and 2 were conducted as interviews with teachers and parents to assess the suitability of the XpressCollect for children in kindergarten through eighth grade. Additionally, teacher and parent feedback was obtained to develop and optimize the instructional materials for subsequent phases. In Phases 3 and 4, teachers guided small groups and full classes of students through the sample collection process with XpressCollect. The samples collected by the students were sent to a laboratory to analyze the effectiveness of specimen self-collection based on the presence of ribonuclease P (RNase P) on each nasal swab. The presence of RNase P enables disease determination; thus, student samples were analyzed for adequate or inadequate sampling. All students in kindergarten through eighth grade are capable of self-collecting an anterior nares specimen with XpressCollect, as the laboratory results identified acceptable RNase P Ct values for the samples collected in a classroom setting.
