UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001282
Receipt number R000001561
Scientific Title Efficacy of Pranlukast in subjects with Japanese Cedar pollinosis in the OHIO Chamber
Date of disclosure of the study information 2008/08/04
Last modified on 2009/11/02 13:12:58

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Basic information

Public title

Efficacy of Pranlukast in subjects with Japanese Cedar pollinosis in the OHIO Chamber

Acronym

TOPIC Study ( Trial of OHIO Chamber - Pranlukast Inhibitory Effect for Cedar Exposure -)

Scientific Title

Efficacy of Pranlukast in subjects with Japanese Cedar pollinosis in the OHIO Chamber

Scientific Title:Acronym

TOPIC Study ( Trial of OHIO Chamber - Pranlukast Inhibitory Effect for Cedar Exposure -)

Region

Japan


Condition

Condition

Japanese cedar pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The study objective is to compare the efficacy of Pranlukast and placebo on the subjects with the artificially induced nasal symptoms exposed to a definite concentration of Japanese cedar pollen in the OHIO Chamber.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

nose and eye symptoms

Key secondary outcomes

the number of sneezing, the amount of nasal secretion, the manifestation time of nasal symptoms, nasal airway resistance, respiratory function and performance test( D-CAT )


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Two pranlukast capsules are orally administered after the meal 4 times ( 2 times before the exposure and 2 times after the exposure ). The study consists of 2 times exposure in OHIO Chamber at one week intervals.

Interventions/Control_2

Two placebo capsules are orally administered after the meal 4 times ( 2 times before the exposure and 2 times after the exposure ). The study consists of 2 times exposure in OHIO Chamber at one week intervals.

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Subjects must have at least a 2-year history of allergic symptoms during the Japanese cedar pollen season, such as sneezing, nasal discharge and nasal obstruction.
2) Subjects must have had blood tests within a 3 years showing positive CAP-RAST scores ( between 2 and 6 ) for Japanese cedar pollen.
3) Subjects must be appropriate to this study by the judgment of doctor.
4) Informed consent must be obtained from the subjects prior to study entry.

Key exclusion criteria

1) Subjects with a polyp or deformity of the nose.
2) Subjects who used steroid drugs for injection within 6 months before the start of this study.
3) Subjects with systemic diseases ( asthma or tuberculosis ).
4) Subjects with build-up phase of immunotherapy to Japanese cedar pollen.
5) Subjects with pregnancy, lactation or potential pregnancy.
6) Subjects who are inappropriate to this study by the judgment of doctor.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kimihiro Okubo

Organization

Nippon Medical School

Division name

Department of Otolaryngology

Zip code


Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email



Public contact

Name of contact person

1st name
Middle name
Last name Minoru Gotoh

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Department of Otolaryngology

Zip code


Address

1715 kamakari inbamura inbagun

TEL

0476-99-1111

Homepage URL


Email



Sponsor or person

Institute

TOPIC Study (Trial of OHIO Chamber-Pranlukast Inhibitory Effect for Cedar Exposure-)

Institute

Department

Personal name



Funding Source

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2008 Year 08 Month 04 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

2008 Year 06 Month 19 Day

Date of IRB


Anticipated trial start date

2008 Year 07 Month 01 Day

Last follow-up date

2008 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 07 Month 31 Day

Last modified on

2009 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001561


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name