UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011565 |
|---|---|
| Receipt number | 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 16:16:33 |
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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].
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
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
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
yamasaki@grape.med.tottori-u.ac.jp
Sponsor or person
Institute
Akira Yamasaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013529
