UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046167 |
|---|---|
| Receipt number | R000052683 |
| Scientific Title | Clinical characteristics of uncontrolled asthmatic patients improved by single-inhaler triple therapy |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/05/29 11:52:52 |
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Basic information
Public title
Clinical characteristics of uncontrolled asthmatic patients improved by single-inhaler triple therapy
Acronym
Clinical characteristics of uncontrolled asthmatic patients improved by single-inhaler triple therapy
Scientific Title
Clinical characteristics of uncontrolled asthmatic patients improved by single-inhaler triple therapy
Scientific Title:Acronym
Clinical characteristics of uncontrolled asthmatic patients improved by single-inhaler triple therapy
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the clinical characteristics of uncontrolled asthmatic patients despite ICS (Inhaled corticosteroid) or ICS/LABA (long-acting beta2-agonist), who have been improved by single-inhaler triple therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of clinical characteristics between the group of uncontrolled asthma improved at least 0.5 point from the baseline ACQ-7 by single-inhaler triple therapy and the group without effect (baseline %FE1, FeNO, exacerbation frequency, peripheral blood eosinophil count, and so on)
Key secondary outcomes
1)Proportion of patients with at least 0.5 decrease in ACQ-7 score
2)Adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
single-inhaler triple therapy for 12 weeks
Interventions/Control_2
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) Patients of both sexes aged 20 years and older
2) Patients with a diagnosis of asthma or cough variant asthma who have been receiving ICS or ICS/LABA for at least four weeks before they participate in the study, and with an ACQ-6 score of at least 1.5 at the screening
3) Patients who signed informed consent form before enrolling the study
Key exclusion criteria
1) Patients with malignant tumor
2) Patients with COPD or patients with a smoking history of 10 pack-years or more
3) Patients with a smoking history in last 6 months
4) Patients with benign prostatic hypertrophy or glaucoma
5) Any patients considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Miura |
Organization
Tohoku Rosai Hospital
Division name
Department of Respiratory Medicine
Zip code
981-8563
Address
4-3-21, Dainohara, Aoba, Sendai, Miyagi-Pref
TEL
0222751111
mmiura@tohokuh.rofuku.go.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Yatsu |
Organization
Tohoku Rosai Hospital
Division name
Department of Respiratory Medicine
Zip code
981-8563
Address
4-3-21, Dainohara, Aoba, Sendai, Miyagi-Pref
TEL
0222751111
Homepage URL
yatsu822009@yahoo.co.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Tohoku Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Tohoku Rosai Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Respiratory Medicine, Tohoku Rosai Hospital
Address
4-3-21, Dainohara, Aoba, Sendai, Miyagi-Pref
Tel
0222751111
yatsu822009@yahoo.co.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
東北労災病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052683
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/11/27 | 2021.研究実施計画書 ３．１０．２７.docなおし.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
