Details

Autor(en) / Beteiligte

• Patel, Mitesh, BMedSci, BMBS, MRCP
• Pilcher, Janine, BSc, MBChB
• Chan, Amy, BPharm(Hons), RegPharmNZ
• Perrin, Kyle, MBChB, FRACP, PhD
• Black, Peter, MBChB, FRACP
• Beasley, Richard, MBChB, DSc

Titel

Six-month in vitro validation of a metered-dose inhaler electronic monitoring device: Implications for asthma clinical trial use

Ist Teil von

• Journal of allergy and clinical immunology, 2012-12, Vol.130 (6), p.1420-1422

Ort / Verlag

United States: Mosby, Inc

Erscheinungsjahr

2012

Quelle

Access via ScienceDirect (Elsevier)

Beschreibungen/Notizen

• [...]we have demonstrated that the Smartinhaler is accurate in recording and retaining MDI actuation data during a 6-month in vitro validation process, provided initial pre-use checks are performed. Monitor function tested Week0 Week8 Week16 Week24 Reset[low *] X X   Loading with medication canister[dagger] X  X  Initial screen of monitor[double dagger] X    Low use actuations§ X X  X High use actuations|| X X  X Actuation time and date X X  X Upload of data to Web site X  X X Preview of data¶  X X  Erroneous actuation check during 8-wk period without use  X   Storage of electronic data for an 8-wk period   X  Accuracy of monitors in recording actuations after 8 wk of no use    X Comparison of uploaded Web site data with diary data   X X Comparison of computer backup data with diary data   X X Monitor clock accuracy over 8 wk    X Monitor battery charge    X Table I Monitor functions tested over the 24-week period Monitor function tested Accuracy Monitors completing full testing period, n (%) 20 (91)[low *] Overall accuracy in recording number of actuations over 24 wk (%) 2170 recorded of 2176 actuations performed (99.7) Accuracy during low use[dagger] (%) 554 recorded of 560 actuations performed (98.9) Accuracy during high use[dagger] (%) 1440 recorded of 1440 actuations performed (100) Accuracy at wk 24 (%) vs accuracy at wk 0-16[dagger] (%) Wk 24: 716 recorded of 720 actuations performed (99.4)Wk 0-16: 1278 recorded of 1280 actuations performed (99.8) Accuracy of recording actuation time and date[double dagger] (%) 2160 actuations accurate of 2176 performed (99.3) No. of extra actuations recorded (% of total) 8 extra actuations§ (0.37) No. of monitors in which extra or missed actuations occurred during testing 2 Ventolin Smartinhalers No. of erroneous actuations during 8 wk without use 0 Data retention for 8 wk (%) 100 Accuracy after 8 wk of no use (%) 716 recorded of 720 actuations performed (99.4) Accuracy of Web site data (%) 100 Accuracy of computer backup of data (%) 100 Mean (SD) monitor clock accuracy (mm:ss)|| 05:10 (00:52) Battery charge at week 24 Full charge for all monitors Table II Results of testing process