UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012877
Receipt number R000014972
Scientific Title Efficacy of preseasonal treatment on the quality of life in seasonal allergic rhinitis
Date of disclosure of the study information 2014/01/17
Last modified on 2023/04/07 13:55:38

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Basic information

Public title

Efficacy of preseasonal treatment on the quality of life in seasonal allergic rhinitis

Acronym

Efficacy of preseasonal treatment on QOL in seasonal allergic rhinitis

Scientific Title

Efficacy of preseasonal treatment on the quality of life in seasonal allergic rhinitis

Scientific Title:Acronym

Efficacy of preseasonal treatment on QOL in seasonal allergic rhinitis

Region

Japan


Condition

Condition

Japanese cedar pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of preseasonal treatment on QOL in subjects with Japanese cedar pollinosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

QOL

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Japanese cedar pollinosis

Key exclusion criteria

Female patients are excluded if they are pregnant or breast-feeding. Patients with nasal polyps or obvious nasal structural abnormalities such as nasal septum deviation, or with acute sinusitis or other upper respiratory infections, are also excluded.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Ikuyo
Middle name
Last name Miyanohara

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Division name

Dept. of Otolaryngology-Head and Neck Surgery

Zip code

890-8520

Address

8-35-1, Sakuragaoka, Kagoshima, 890-8520, Japan

TEL

099-275-5410

Email

iusu33@m2.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Ikuyo
Middle name
Last name Miyanohara

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Division name

Dept. of Otolaryngology-Head and Neck Surgery

Zip code

890-8520

Address

8-35-1, Sakuragaoka, Kagoshima, 890-8520, Japan

TEL

099-275-5410

Homepage URL


Email

entjm@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Dept. of Otolaryngology-Head and Neck Surgery
Kagoshima University Graduate School of Medical and Dental Sciences

Institute

Department

Personal name



Funding Source

Organization

Dept. of Otolaryngology-Head and Neck Surgery
Kagoshima University Graduate School of Medical and Dental Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Dept. of Otolaryngology-Head and Neck Surgery Kagoshima University Graduate School of Medical and Dental Sciences

Address

8-35-1, Sakuragaoka, Kagoshima, 890-8520, JAPAN

Tel

099-275-5410

Email

entjm@m.kufm.kagoshima-u.ac.jp


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 01 Month 17 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

2014 Year 01 Month 07 Day

Date of IRB

2014 Year 01 Month 07 Day

Anticipated trial start date

2014 Year 01 Month 17 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information

This study is planned to evaluate the efficacy and safety of preseasonal treatment in subjects with JC pollinosis, based on evaluation of quality of life (QOL).QOL was surveyed using the Japanese Allergic Rhinitis QOL Standard Questionnaire (JRQLQ) No.1 during the pollen season on the website.


Management information

Registered date

2014 Year 01 Month 16 Day

Last modified on

2023 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014972


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name