UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044134 |
|---|---|
| Receipt number | R000050394 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2021/05/08 |
| Last modified on | 2021/05/07 17:17:21 |
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Basic information
Public title
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and examine 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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in ACT score from baseline 12 weeks after the start of administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
Interventions/Control_2
Standard treatment (asthma treatment other than inhaled drugs that participants have used before participating the study) plus fluticasone furoate 100ug plus umeclidinium 62.5ug plus vilanterol 25ug for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YOSHITO |
| Middle name | |
| Last name | MIYATA |
Organization
Showa University School of Medicine
Division name
Department of Internal Medicine, Division of Respiratory Medicine and Allergology,
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8538
ym820127@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | YOSHITO |
| Middle name | |
| Last name | MIYATA |
Organization
Showa University School of Medicine
Division name
Department of Internal Medicine, Division of Respiratory Medicine and Allergology,
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8538
Homepage URL
ym820127@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 07 | Day |
Last modified on
| 2021 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050394
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| Registered date | File name |
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