UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010380
Receipt number R000011846
Scientific Title Olfactory dysfunction in asthma patients
Date of disclosure of the study information 2013/04/02
Last modified on 2017/02/07 12:23:39

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Basic information

Public title

Olfactory dysfunction in asthma patients

Acronym

asthma and olfactory disfunction

Scientific Title

Olfactory dysfunction in asthma patients

Scientific Title:Acronym

asthma and olfactory disfunction

Region

Japan


Condition

Condition

asthma

Classification by specialty

Pneumology Clinical immunology Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reveal the prevalence of olfactory dysfunction in asthma patients.

Basic objectives2

Others

Basic objectives -Others

Phnotype of asthma

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Questionare about olfaction
VAS scale of olfaction
Open Essense Method

Key secondary outcomes

ACT Questionare
ExNO
Medcation


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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

asthma patients

Key exclusion criteria

none

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Kamijo

Organization

Saitama Medical University

Division name

Otorhinolaryngology, Allergy Center

Zip code


Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan

TEL

049-276-1253

Email

atkamijo@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Kamijo

Organization

Saitama Medical University

Division name

Otorhinolaryngology

Zip code


Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan

TEL

049-276-1253

Homepage URL


Email

atkamijo@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Dept Otorhinolaryngology and Allergy Center, Satitama Medical Univeirsity

Organization

Division

Category of Funding Organization

Self funding

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

2013 Year 04 Month 02 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

Completed

Date of protocol fixation

2013 Year 02 Month 14 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date

2013 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete

2013 Year 06 Month 30 Day

Date analysis concluded

2013 Year 09 Month 30 Day


Other

Other related information

None


Management information

Registered date

2013 Year 04 Month 01 Day

Last modified on

2017 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011846


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name