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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013529


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name