肺与呼吸系统医学

Critical Steps: A Non-Interventional, Multicenter, Prospective, Observational Study on Critical Handling Errors with DPI Use, in Asthma and COPD Patients

Abstract

Demosthenes Bouros and Mina N Evangeliou

Objective: Correct inhalation technique is crucial for drug delivery to the airways of Asthma and COPD patients. The aim of the current study is to assess the usability of three commonly used DPI devices in Greece in Asthma and COPD patients.

Methods: This was a non-interventional, multicenter, observational study that enrolled 755 patients (409 Asthma and 346 COPD). Evaluation of device use was performed at baseline (day 0), immediately after correct use demonstration by the investigator, and final visit (day 30). Assessment was based on 8-step device-specific checklists where all the required inhalation maneuvers were described. Primary variable was the number of critical errors observed during baseline and final visit. The ACQ and CAT questionnaires were used to record patients’ perspective about their condition, and the FSI-10 questionnaire to depict patients’ feeling of satisfaction from inhaler use.

Results: More than 70% of the patients performed all inhalation maneuvers correctly right after the first demonstration by pneumonologist. At final visit approximately 85% of Diskus®, 93% of Elpenhaler®, and 75% of Turbuhaler® users did not make critical errors that affect drug delivery to the lungs. Elpenhaler® had the lower error rates for critical steps at baseline and final visits (7.0% and 2.5% respectively), whereas the corresponding rates for Diskus® were 7.3% and 4.9%, and for Turbuhaler®, 8.5% and 7% respectively. All patients had improved ACQ and CAT scores and were at least fairly satisfied by their inhalers.

Conclusions: Demonstration of inhalation technique is of paramount importance, while prescribing an inhaled therapy. Improvement over one-month use was more evident in Elpenhaler® device. The lower error rates on critical steps for Elpenhaler® reported at baseline and final visits in combination with the observed improvements in ACQ, CAT and FSI-10 scores suggest better adherence to therapy and disease control.