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The efficacy of high-dose ICS / LABA or medium-dose inhaled ICS / LABA / LAMA in patients with poor asthma control under medium-dose ICS / LABA administration

The efficacy of high-dose ICS / LABA or medium-dose inhaled ICS / LABA / LAMA in patients with poor asthma control under medium-dose ICS / LABA administration - The efficacy of high-dose ICS / LABA or medium-dose inhaled ICS / LABA / LAMA in patients with poor asthma control under medium-dose ICS / LABA administration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044134
Enrollment
30
Registered
2021-05-08
Start date
2021-05-10
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

Standard treatment (asthma treatment other than inhaled drugs that participants have used before participating the study) plus fluticasone furoate 200ug plus vilanterol trifenatate25ug for 12 weeks S

Sponsors

Showa University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Asthma patients visiting the outpatient department of respiratory and allergy medicine at Showa University Hospital 2) Patients whose age at the time of obtaining consent is 20 years or older (regardless of gender) 3) Patients who have no problem with the ellipta inhalation procedure (confirm the inhalation procedure with a practice device before the observation period) 4) Patients with a total ACT score of less than 20 4 weeks after obtaining consent 5) Non-smokers (<10 pack years) 6) Patients who have given written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1) Patients with bronchiectasis, diffuse panbronchiolitis, collagen disease, pulmonary hypertension, sequelae of tuberculosis, interstitial pneumonia, chronic obstructive pulmonary disease 2) Patients who received oral or intravenous steroids with a diagnosis of exacerbation of asthma within 4 weeks before obtaining consent Person 3) Malignant tumor: Patients currently affected or within 1 year after remission 4) Patients diagnosed with eosinophilia syndrome and eosinophilic polyangiitis granulomatosis 5) Patients with a history of parasite infection within the past 6 months 6) Patients who have been or have been receiving biopharmacy within 6 months 7) Patients who have undergone bronchial hyperthermia within the past year 8) Patients diagnosed with angle-closure glaucoma 9) Patients receiving medication for the diagnosis of benign prostatic hyperplasia 10) Patients judged to be ineligible by the judgment of the research doctor

Design outcomes

Primary

MeasureTime frame
Amount of change in ACT score from baseline 12 weeks after the start of administration

Countries

Japan

Contacts

Public ContactYOSHITO MIYATA

Showa University School of Medicine Department of Internal Medicine, Division of Respiratory Medicine and Allergology,

ym820127@med.showa-u.ac.jp03-3784-8538

Outcome results

None listed

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