Selection Study

JRCT ID: jRCTs041180001

Registered date:21/08/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Asthma
• Date of first enrollment: 03/09/2018
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Randomization and Cross-over

Outcome(s)

• Primary Outcome: Satisfactory level of patient for inhaler devices (Overall satisfaction)

Secondary Outcome

Satisfactory level of patient for inhaler devices (other item-score and comments for devices)
MostGraph
Inhalation technique
Questionnaire for device impression
Adherence
JACS (Japan Asthma Control Survey)
ACQ
Safety including side effect and adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Ohbayashi Hiroyuki
• Source(s) of Monetary Support: Kyorin Pharmaceutical Co., Ltd.