UMIN-CTR Clinical Trial

Public title

The effect of early intervention for the patients with Japanese cedar pollinosis by Pranlukast Hydrate in the OHIO Chamber.

Acronym

TOPIC-J STUDY 2(Trial of OHIO Chamber Pranlukast inhibitory effect for cedar exposure)

Scientific Title

The effect of early intervention for the patients with Japanese cedar pollinosis by Pranlukast Hydrate in the OHIO Chamber.

Scientific Title:Acronym

TOPIC-J STUDY 2(Trial of OHIO Chamber Pranlukast inhibitory effect for cedar exposure)

Region

Japan

Condition

Japanese cedar pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Administered 1 month from Feb. 29 through Feb. 01, Pranlukast or placebo in patients with Japanese cedar pollinosis, just before the cedar pollen dispersal (mid-Feb.) and nasal symptoms induced by OHIO Chamber to determine the effectiveness of Pranlukast in early intervention of cedar pollinosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Nasal symptoms score

Key secondary outcomes

1) No of sneezing
2) Nasal secretion volume
3) Occurrence time of the first nasal symptom

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pranlukast Hydrate capsules are orally administered to 15 subjects at twice daily one month from Feb. 29 through Feb. 01.
Japanese cedar pollen exposure mid-Feb. in OHIO Chamber.

Interventions/Control_2

Placebo capsules are orally administered to 15 subjects at twice daily one month from Feb. 29 through Feb. 01.
Japanese cedar pollen exposure mid-Feb. in OHIO Chamber.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1) CAP-RAST score against Japanese cedar pollen over class 2 in the past.
2) Have experience with cedar pollen exposure in the OHIO Chamber in the past, patients with nasal symptoms with nasal congestion.
3) Patients who were judged to be suitable for patients enrollment by doctor in screening visit or medical examination results.
4) Written informed consent is required.

Key exclusion criteria

1) Some patients with mucosal lesion of the nose and eyes.
2) Patients who received steroid injections within 6 months.
3) Subjects with deformity of the nose or a polyp.
4) Subjects with systemic diseases (asthma or tuberculosis).
5) Patients with past history of anaphylaxis.
6) Patients who have the hypersensitivity to study drug.
7) Patients who have received immunotherapy.
8) Pregnancy, breast-feeding woman, potencial pregnancy, patients who wish to become pregnant during this study.
9) Patients who were judged to be unsuitable for patients enrollment by doctor.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kimihiro Okubo

Organization

Nippon Medical School

Division name

Department of Otorhinolaryngology and Head /Neck Surgery

Zip code

Address

1-1-5 Sendagi, Bunkyo-ku Tokyo 113-8603, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Kiyochika Suematsu

Organization

Medical Corporation Shinanokai, Samoncho Clinic

Division name

Pharmaceutical Dept.,

Zip code

Address

Yotsuya Medical Bldg., 20, Samon-cho, Shinjuku-ku, Tokyo, 160-0017, Japan

TEL

03-5366-3641

Homepage URL

Email

ki-suematsu@samoncho-clinic.jp

Institute

Nippon Medical School

Institute

Department

Personal name

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団信濃会　左門町クリニック　Medical Corporation Shinanokai, Samoncho Clinic

Date of disclosure of the study information

2012

Year

01

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

01

Month

10

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

2012

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

01

Month

31

Day

Last modified on

2012

Year

03

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008457