UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011408 |
|---|---|
| Receipt number | R000013346 |
| Scientific Title | Efficacy of pranlukast for nasal symptoms and physical activity in asthma children with moderate/severe allergic rhinitis |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2013/08/07 16:50:29 |
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Basic information
Public title
Efficacy of pranlukast for nasal symptoms and physical activity in asthma children with moderate/severe allergic rhinitis
Acronym
Pranlukast for rhinitis and physical activity in children
Scientific Title
Efficacy of pranlukast for nasal symptoms and physical activity in asthma children with moderate/severe allergic rhinitis
Scientific Title:Acronym
Pranlukast for rhinitis and physical activity in children
Region
| Japan |
Condition
Condition
allergic rhinitis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Allergic rhinitis is the most prevalent co-morbid disorder in children with asthma. It is a major risk factor for onset and exacerbation of asthma and bothersome symptoms such as nasal obstruction impair quality of life in children. We have observed that physical activity in boys with allergic rhinitis was significantly lower than healthy counterparts. A leukotriene receptor antagonist, pranlukast, has been reported to be effective in ameliorating symptoms of asthma and allergic rhinitis and in improving quality of life of the patients. The aim of the study is to investigate whether pranlukast is efficacious for not only nasal symptoms but also for physical activity in asthma children with moderate/severe asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
symptom score of allergic rhinitis
Key secondary outcomes
physical activity evaluated by using an accelerometer, Lifecorder EX
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
leukotriene receptor antagonist, pranlukast
Interventions/Control_2
antihistamine, fexofenadine
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
| 7 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male
Key inclusion criteria
Eligible patients fulfill the following conditions;
1) House dust mite-sensitized perennial allergic rhinitis with moderate/severe symptom of nasal obstruction based on Practical guideline for the management of allergic rhinitis in Japan 2013
2) Well-controlled bronchial asthma
Key exclusion criteria
1) leukotriene receptor antagonists within 2 weeks before study entry
2) antihistamines within 2 weeks before study entry
3) nasal corticosteroids and/or nasal antihistamines within 2 weeks before study entry
4) systemic corticosteroids within 4 weeks before study entry
5) chronic diseases other than allergy
6) disability or dysfunction of physical activity
7) patients whom a study physician considers inappropriate for the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Fujisawa |
Organization
Mie National Hospital
Division name
Department of Clinical Research
Zip code
Address
357 Osato-kubota, Tsu, Mie, Japan
TEL
059-232-2531
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mizuho Nagao |
Organization
Mie National Hospital
Division name
Department of Clinical Research
Zip code
Address
357 Osato-kubota, Tsu, Mie, Japan
TEL
059-232-2531
Homepage URL
nagaomizuho@mie-m.hosp.go.jp
Sponsor or person
Institute
Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Allergy 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
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
国立病院機構三重病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 07 | Day |
Last modified on
| 2013 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013346
