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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001282
Receipt No. 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

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

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
URL(English) https://upload.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


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