Satisfactory level of patients for inhaler devices with asthma medications; Formoterol fumarate hydrate / Fluticasone propionate (pMDI) vs Vilanterol trifenatate / Fluticasone furoate (Ellipta) randomized open-label cross-over study - Satisfactory level of patients for inhaler devices with asthma medications; Formoterol fumarate hydrate / Fluticasone propionate (pMDI) vs Vilanterol trifenatate / Fluticasone furoate (Ellipta) ==Selection Study==

Ohbayashi Hiroyuki0 个研究点目标入组 44 人开始时间: 2018年8月21日最近更新: 2023年10月17日

适应症

试验速览

Although both devices possessed high satisfaction, operability, and adherence, pMDI showed a higher satisfaction level in the elderly than VFC.

•1) Patients with asthma over the age of 20 years.
•2) Patients who can provide written consent with sufficient understanding of participation after receiving a detailed explanation of the study protocols before providing consent.
•3) Patients who have been using medium dose of dry powder type ICS/LABA for treatment
•4) Patients who retained good level of drug adherence to prior drug therapy after check of inhalation technique
•5) No history of FFC and VFC use
•6) Patients who have been using same devices more than 3 months before enrollment
•7) ACQ (Asthma Control Questionnaire) score less than or equal to 0.75
•8) Mild persistent asthma or moderate persistent asthma with step 2 or step 3 treatment according to the Asthma Prevention and Management Guideline 2015.

•1) Patients with complication to influence the evaluation of devices (such as dementia), patients who can not fill out the questionnaire.
•2) Patients with obvious COPD as complication
•3) Patients not to use device properly because of insufficient finger function due to deformation or paralysis, according to the judgment of the principal investigator
•4) Patients who are not able to understand how to handle inhaler devices for such as dementia, according to the judgment of the principal investigator
•5) Patients who are complicated with severe respiratory, heart, gastrointestinal, urinary, blood, kidney diseases or other severe comorbidities
•6) Cancer complications and history within 5 years

发起方

Ohbayashi Hiroyuki