UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020445
Receipt number R000023622
Scientific Title Efficacy of sublingual immunotherapy (SLIT) in asthmatic patients with cedar pollen rhinoconjunctivitis
Date of disclosure of the study information 2016/01/06
Last modified on 2020/11/27 22:00:27

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Basic information

Public title

Efficacy of sublingual immunotherapy (SLIT) in asthmatic patients with cedar pollen rhinoconjunctivitis

Acronym

Efficacy of SLIT in asthma

Scientific Title

Efficacy of sublingual immunotherapy (SLIT) in asthmatic patients with cedar pollen rhinoconjunctivitis

Scientific Title:Acronym

Efficacy of SLIT in asthma

Region

Japan


Condition

Condition

Asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The main objective of this study was to elucidate whether sublingual immunotherapy (SLIT) are efficacy in asthmatic patients with cedar pollen rhinoconjunctivitis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

symptom status of asthma

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

-Asthmatic patients with cedar pollen rhinoconjunctivitis has a serum cedar pollen-specific IgE levels of at least Class 2
-Participant demonstrates understanding and has provided an appropriately signed and dated informed consent

Key exclusion criteria

-Malignancy
-Infectious disease
-Interstitial pneumonia
-Administration of systemic corticosteroid
-Is unlikely to cooperate with the requirements of the study including having the ability to communicate with the investigator appropriately.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Norihiro
Middle name
Last name Harada

Organization

Juntendo University school of medicine

Division name

Department of respiratory medicine

Zip code

113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

TEL

03-5802-1063

Email

nor@juntendo.ac.jp


Public contact

Name of contact person

1st name Jun
Middle name
Last name Ito

Organization

Juntendo University school of medicine

Division name

Department of respiratory medicine

Zip code

113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

TEL

03-5802-1063

Homepage URL


Email

moisture@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University Faculty of Medicine and Graduate School of Medicine, Department of respiratory medicine

Institute

Department

Personal name



Funding Source

Organization

Juntendo University Faculty of Medicine and Graduate School of Medicine

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

Juntendo University Research Ethics Committee

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-3813-3111

Email

chiken@juntendo.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

順天堂大学医学部呼吸器内科学講座


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 06 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

24

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

2015 Year 11 Month 01 Day

Date of IRB

2015 Year 10 Month 23 Day

Anticipated trial start date

2016 Year 01 Month 06 Day

Last follow-up date

2020 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The method of recruitment;
Subjects having any of the inclusion criteria will be recruited from our outpatient clinic at Juntendo University Hospital by December 1, 2019.


Management information

Registered date

2016 Year 01 Month 05 Day

Last modified on

2020 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023622


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name