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Selection Study

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==

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041180001
Enrollment
40
Registered
2018-08-21
Start date
2018-09-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

Randomization and Cross-over

Sponsors

Ohbayashi Hiroyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Satisfactory level of patient for inhaler devices (Overall satisfaction)

Secondary

MeasureTime frame
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

Contacts

Public ContactHiroyuki Ohbayashi

Tohno Chuo Clinic

aims_reserve@yahoo.co.jp+81-572-67-1118

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026