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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011565
Receipt No. R000013529
Scientific Title Assessment of step-down of inhaled corticosteroids (ICS) in patients with controlled asthma
Date of disclosure of the study information 2013/09/01
Last modified on 2013/08/23

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Basic information
Public title Assessment of step-down of inhaled corticosteroids (ICS) in patients with controlled asthma
Acronym Prediction of future risk in patients with controlled asthma during step-down of ICS
Scientific Title Assessment of step-down of inhaled corticosteroids (ICS) in patients with controlled asthma
Scientific Title:Acronym Prediction of future risk in patients with controlled asthma during step-down of ICS
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is warranted to prospectively assess a prognostic factor, which can accurately predict clinical deterioration of asthma in well-controlled patients who are undergoing a step-wise down-titration of their medication according to international guidelines, for use in the clinical rather the research setting.
Basic objectives2 Others
Basic objectives -Others Exacerbation. [Time Frame: 12 months]
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Severe exacerbation: requiring oral steroids, emergency visits or hospitalization [Time Frame: 12 months].
Key secondary outcomes Intermittent withdrawal of step-down judged by their attending physician according to worsen symptoms [Time Frame: 12 months].

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Adults (age between 18 and 80).
2) Asthma under control during the last 3 months. (Juniper Asthma Questionnaire < 1 point).
3) Treated with a combination of ICS and long-acting beta-agonist (LABA) or ICS alone.
4) Written informed consent.
Key exclusion criteria 1) Patients with uncontrolled co-morbid diseases such as cardio-vascular disease, cerebral disease, renal disease, endocrine disease and gastrointestinal disease.
2) Pregnancy and woman who is lactating or if of childbearing potential.
3) Treatment with oral corticosteroids or immunosuppressant therapy.
4) Patients with seasonal exacerbations and predicted worsen of symptoms within one year.
5) Unsuitable for the study in the judgment of their attending physician.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Yamasaki
Organization Tottori University Faculty of Medicine
Division name Department of Third Internal Medicine, Respiration/Collagen and Vascular Disease
Zip code
Address 36-1 Nishimachi, Yonago, Tottori, 683-8504, Japan
TEL +81-859-38-6537
Email yamasaki@grape.med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamasaki
Organization Tottori University Faculty of Medicine
Division name Department of Third Internal Medicine, Respiration/Collagen and Vascular Disease
Zip code
Address 36-1 Nishimachi, Yonago, Tottori, 683-8504, Japan
TEL +81-859-38-6537
Homepage URL
Email yamasaki@grape.med.tottori-u.ac.jp

Sponsor
Institute Akira Yamasaki
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sanin Asthma Group
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 米子医療センター(鳥取県)
山陰労災病院(鳥取県)
松江赤十字病院(島根県)
松江市立病院(島根県)
松江医療センター(島根県)
境港済生会病院(鳥取県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 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
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 08 Month 31 Day
Date trial data considered complete
2015 Year 08 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information Analysis using propensity score

Management information
Registered date
2013 Year 08 Month 23 Day
Last modified on
2013 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013529


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