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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046167
Receipt No. 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 2021/11/24

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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
Email 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
Email yatsu822009@yahoo.co.jp

Sponsor
Institute Department of Respiratory Medicine, Tohoku Rosai Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 24 Day
Date of IRB
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
2021 Year 11 Month 24 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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