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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024787
Receipt No. 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

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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
Email 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
Email y.nagaoka@city-hosp.naka.hiroshima.jp

Sponsor
Institute Department of Pediatrics, Hiroshima City Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028513

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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