UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002436
Receipt number R000002914
Scientific Title Effect of exposure and sensitization to indoor allergens on asthma control level
Date of disclosure of the study information 2009/09/09
Last modified on 2012/09/03 15:46:16

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Basic information

Public title

Effect of exposure and sensitization to indoor allergens on asthma control level

Acronym

Effect of exposure and sensitization to indoor allergens on asthma control level

Scientific Title

Effect of exposure and sensitization to indoor allergens on asthma control level

Scientific Title:Acronym

Effect of exposure and sensitization to indoor allergens on asthma control level

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of exposure and sensitization to indoor allergens on asthma control level

Basic objectives2

Others

Basic objectives -Others

cross-sectinal study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

exposure and sensitization score to indoor allergens

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

adult patients with bronchial asthma who attending outpatient clinics at Shizuoka General Hospital

Key exclusion criteria

patients whom the doctor considers inappropriate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihiro Shirai

Organization

Shizuoka General Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

4-27-1 Kita-ando, Aoi, Shizuoka

TEL

054-247-6111

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Shizuoka General Hospital

Division name

Department of Respiratory Medicine

Zip code


Address


TEL


Homepage URL


Email

tmjkshi@general-hosp.pref.shizuoka.jp


Sponsor or person

Institute

Shizuoka General Hospital, Department of Respiratory Medicine

Institute

Department

Personal name



Funding Source

Organization

Government

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2009 Year 09 Month 09 Day


Related information

URL releasing protocol

http://ai.jsaweb.jp/

Publication of results

Published


Result

URL related to results and publications

http://ai.jsaweb.jp/

Number of participants that the trial has enrolled


Results

Sixty-nine patients were exposed to high levels (> 10 microg/g dust for Der 1 and Can f 1 and > 8 microg/g dust for Fel d 1) of 1 or more allergens and 39 patients were sensitized to at least one allergen. Multivariate logistic regression analyses revealed that the FEV1 (% of predicted value) was associated with low ACT scores (&#8804; 19) and that the number of highly exposed allergens and inhaled corticosteroid dose were associated with a low level of Min%Max PEF (< 80%).

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

Completed

Date of protocol fixation

2008 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 04 Month 01 Day

Last follow-up date

2012 Year 09 Month 03 Day

Date of closure to data entry

2012 Year 09 Month 03 Day

Date trial data considered complete

2012 Year 09 Month 03 Day

Date analysis concluded

2012 Year 09 Month 03 Day


Other

Other related information

Dust samples were obtained from the patients' houses and indoor allergen levels were measured.


Management information

Registered date

2009 Year 09 Month 02 Day

Last modified on

2012 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002914


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name