UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003825 |
|---|---|
| Receipt number | 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 08:48:08 |
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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
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
Sponsor or person
Institute
Samoncho Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004609
