TY - JOUR T1 - A novel NEXT DPI® dry powder inhaler and its use in asthmatic and COPD population JF - European Respiratory Journal JO - Eur Respir J VL - 38 IS - Suppl 55 SP - p831 AU - F. Sergio AU - A. Chetta AU - G. Pisi AU - M. Aiello AU - D. Olivieri Y1 - 2011/09/01 UR - http://erj.ersjournals.com/content/38/Suppl_55/p831.abstract N2 - Rationale: In asthma and COPD the dry powder inhalers (DPIs) facilitate patient's compliance to drug intake. Chiesi Farmaceutici developed a new inhaler, NEXT DPI® which is pocket size medium-resistant breath-actuated mechanism (BAM) multidose-reservoir to be used for drug delivery.Objective: To verify that the peak inspiratory flow (PIF) required for the drug delivery is not influenced by patient's age and disease.Methods: Children (n=27; age 5-11), adolescents (n=20; age 12-17) and adults (n=21; age ≥ 18) with asthma and COPD patients (n=21; age ≥ 40) were included in this multicenter open-label placebo study. After baseline pulmonary function assessments (FEV1, FVC; PIF tested with spirometer and In-Check Dial™ device) patients inhaled through the NEXT DPI® to test the BAM activation, checked by the residual doses in the dose-counter. Usability evaluation questionnaire, adverse events (AE) and vital signs were also recorded.Results: In all patients, spirometry showed from moderate to severe airways obstruction. All patients, irrespective of age and disease, were able to activate the BAM. The mean PIF value (asthmatic patients: 104.4±20.6 L/min, range 40-120; COPD patients: 97.9±18.8 L/min, range 51-120) measured with the In-Check was greater than the threshold set for the BAM activation and not influenced by age and disease severity. No patients had problem in using the NEXT DPI® correctly. A total of 7 AEs were reported in 5 patients, no one related with the use of NEXT DPI® or severe in intensity. No Severe Adverse Events were reported.Conclusions: NEXT DPI® can be easily used and activated in a wide population of asthmatics and COPD patients irrespective of age and disease severity. ER -