UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015667
Receipt number R000018209
Scientific Title The study of allergic laryngitis using an environmental challenge chamber
Date of disclosure of the study information 2014/11/11
Last modified on 2014/11/11 21:28:13

* 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

The study of allergic laryngitis using an environmental challenge chamber

Acronym

The study of allergic laryngitis

Scientific Title

The study of allergic laryngitis using an environmental challenge chamber

Scientific Title:Acronym

The study of allergic laryngitis

Region

Japan


Condition

Condition

Allergic laryngitis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

pathological elucidation of allergic laryngitis

Basic objectives2

Others

Basic objectives -Others

pathological condition

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

laryngeal symptoms score

Key secondary outcomes

ECP


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Cedar pollen

Interventions/Control_2

Cypress pollen

Interventions/Control_3

Cedar pollen with nasal plug

Interventions/Control_4

control with nasal plug

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

a history of rhinitis for at least 2 consecutive cedar and cypress pollen seasons and met the following inclusion criteria: a serum both cedar and cypress pollen-specific IgE score >2 in a CAP-radioallergosorbent test

Key exclusion criteria

nasal diseases including AR induced by other allergens, asthma, cough variant asthma, gastroesophageal reflux disease, post nasal discharge, history of having a cold within 2 weeks, use of antiallergic drugs within 4 weeks before each study, abnormal patients in respiratory function test, patients who are sensitive in the larynx before the study, women who were pregnant or planned to become pregnant during the study period and breastfeeding women.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Okamoto

Organization

University of Chiba

Division name

Otolaryngology

Zip code


Address

1-8-1 Inohana Tyuo-ku Chiba city, Chiba

TEL

+81432227171

Email

ttn3hyi@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Suzuki

Organization

University of Chiba

Division name

Otolaryngology

Zip code


Address

1-8-1 Inohana Tyuo-ku Chiba city, Chiba

TEL

+81432227171

Homepage URL


Email

ttn3hyi@yahoo.co.jp


Sponsor or person

Institute

University of Chiba, Department of Otolaryngology

Institute

Department

Personal name



Funding Source

Organization

University of Chiba, Department of Otolaryngology

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

2014 Year 11 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


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 04 Month 22 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 11 Month 11 Day

Last modified on

2014 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018209


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name