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Recruitment status Completed
Unique ID issued by UMIN UMIN000004585
Receipt No. R000005459
Scientific Title Effect of Pranlukast on allergic symptoms and nasal Nitric oxide levels in patients with Japanese cedar pollinosis
Date of disclosure of the study information 2010/11/28
Last modified on 2011/05/25

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Basic information
Public title Effect of Pranlukast on allergic symptoms and nasal Nitric oxide levels in patients with Japanese cedar pollinosis
Acronym PRAN study
Scientific Title Effect of Pranlukast on allergic symptoms and nasal Nitric oxide levels in patients with Japanese cedar pollinosis
Scientific Title:Acronym PRAN study
Region
Japan

Condition
Condition Patients with Japanese cedar pollinosis
Classification by specialty
Clinical immunology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of measuring nasal nitric oxide (NO) levels as a disease marker in patients with Japanese cedar pollinosis, and to see the effect of pranlukast on allergic symptoms and nasal NO levels in those patients.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes nasal NO levels, symptoms score, volume of nasal secretion, number of seezing
Key secondary outcomes

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
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pranlukast
Interventions/Control_2 placebo
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
19 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Patients with Japanese cedar pollinosis
Key exclusion criteria Patients with respiratory diseases such as asthma.
Patients with past history of anaphylaxis.
Patients with hypersensitivity to pranlukast.
Pregnant woman or breast-feeding woman.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshi Katsunuma
Organization The Jikei University School of Medicine
Division name Deapartment of Pediatrics, Jikei Daisan Hospital
Zip code
Address 4-11-1, Izumihoncho, Komae City, Tokyo
TEL 03-3480-1151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Katsunuma
Organization PRAN study group
Division name PRAN study office
Zip code
Address Deapartment of Pediatrics, Jikei Daisan Hospital
TEL
Homepage URL
Email

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University Research Fund
Organization
Division
Category of Funding Organization Other
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
2010 Year 11 Month 28 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
2010 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 18 Day
Last modified on
2011 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005459

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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