UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024787 |
|---|---|
| Receipt number | R000028513 |
| Scientific Title | Recurrent chronic cough, wheeze triggered by RS virus infection and their control with leukotriene receptor antagonists (LTRAs: montelukast, pranlukast), carbocystein and ambroxol |
| Date of disclosure of the study information | 2016/11/15 |
| Last modified on | 2016/11/10 11:59:56 |
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Basic information
Public title
Recurrent chronic cough, wheeze triggered by RS virus infection and their control with leukotriene receptor antagonists (LTRAs: montelukast, pranlukast), carbocystein and ambroxol
Acronym
Recurrent chronic cough, wheeze triggered by RS virus infection and their control
Scientific Title
Recurrent chronic cough, wheeze triggered by RS virus infection and their control with leukotriene receptor antagonists (LTRAs: montelukast, pranlukast), carbocystein and ambroxol
Scientific Title:Acronym
Recurrent chronic cough, wheeze triggered by RS virus infection and their control
Region
| Japan |
Condition
Condition
Recurrent chronic cough, wheeze triggered by RS virus infection during early childhood
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recurrent persistent cough and wheezing often begin in early childhood, and they are exacerbated with RS rirus infection. The best treatment for toddlers and pre-school-age children is a important clinical challenge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Main evaluation
Decrease in freequency of wheezing and chronic cough (every 1-2 months).
Key secondary outcomes
2) Second evaluation
Modified ACT test (cough, sleepless, activity), frequency of respiratory accidents.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control (LTRA only, for 6 months to one year)
Interventions/Control_2
+treatment (LTRA + carbocystein and ambroxol, for 6 months to one year)
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
| 6 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
RS virus-infected children who suffered from bronchiolitis and was considered for hospitalization (SpO2 < 92%)
Key exclusion criteria
excluding typical atopic patients (IgE <150 IU)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kozo Yasui |
Organization
Hiroshima City Hospital
Division name
Department of Pediatrics
Zip code
Address
Moto-Machi 7-33, Naka-Ku Hiroshima 730-8518
TEL
082-221-2291
k-yasui@city-hosp.naka.hiroshima.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Nagaoka |
Organization
Hiroshima City Hospital
Division name
Department of Pediatrics
Zip code
Address
Moto-Machi 7-33, Naka-Ku Hiroshima 730-8518
TEL
082-221-2291
Homepage URL
y.nagaoka@city-hosp.naka.hiroshima.jp
Sponsor or person
Institute
Department of Pediatrics, Hiroshima City Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Hiroshima City Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okayama University Hospital
Nihon-Kokan Fukuyama Hospital
Osaka Center of Respiratology and Allergy
Dokkyomedical School Hospital
Nagano Red Cross Hospital
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
広島市立広島市民病院 岡山大学病院 福山医療センター（広島県） 日本鋼管福山病院（広島県）
大阪府立呼吸器・アレルギーセンター 独協医科大学付属病院（栃木県）
長野赤十字病院 （長野県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 10 | Day |
Last modified on
| 2016 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028513
