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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003825
Receipt No. R000004609
Scientific Title Nasal provocation test in pediatric patients with perennial allergic rhinitis
Date of disclosure of the study information 2010/06/25
Last modified on 2010/09/05

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Basic information
Public title Nasal provocation test in pediatric patients with perennial allergic rhinitis
Acronym Nasal provocation test in pediatric patients with perennial allergic rhinitis
Scientific Title Nasal provocation test in pediatric patients with perennial allergic rhinitis
Scientific Title:Acronym Nasal provocation test in pediatric patients with perennial allergic rhinitis
Region
Japan

Condition
Condition perennial allergic rhinitis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the validity of the nasal provocation test in the clinical setting in pediatric patients with perennial allergic rhinitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Subjective and objective symptoms
Key secondary outcomes results of rhinomanometry

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Disc for nasal provocation
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
10 years-old <=
Age-upper limit
14 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with perennial allergic rhinitis who have at least a 2-year history of allergic symptoms.
2. Patients who have had blood test within 2 years showing positive UniCAP scores for housedust/mite.
3.Patients and their parents who given informed consent
Key exclusion criteria 1. Patients with acute rhinits, simple rhinitis, atgrophic rhinitis, and sinusitis.
2. Patients with nasal obstruction attributable to nasal polyps or nasal deformity.
3. Patients who have undergone immunotherapy with housedust/mite.
4. Patients who have undergone nasal operation such as turbinectomy, choncotomy, and laser surgery.
5. Patients who show complete nasal obstruction after induced a control disc.
6. Patients with uncontrolled asthma.
7. Patients with severe drug allergy.
8. Patients who used anti-allergic or anti-histamine drugs within one week or steroid within one month prior to the start of this study.
9. Patients with allergic diseases except allergic rhinitis such as atopic dermatitis or food allergy which might not show exacerbation after nasal provocation test.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Hashiguchi
Organization Kitasato University Kitsato institute Hospital
Division name Otolaryngology
Zip code
Address 5-9-1 Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL 03-3444-6161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiyochika Suematsu
Organization Samoncho Clinc
Division name Administration department
Zip code
Address 20 Samontyo, Shinjyuku-ku, Tokyo 160-0017, Japan
TEL 03-5366-3641
Homepage URL
Email

Sponsor
Institute Samoncho Clinic
Institute
Department

Funding Source
Organization None
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
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 左門町クリニック

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 25 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 05 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2010 Year 06 Month 01 Day
Date of closure to data entry
2010 Year 07 Month 01 Day
Date trial data considered complete
2010 Year 10 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 25 Day
Last modified on
2010 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004609

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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