UMIN-CTR Clinical Trial

Basic information
Public title	A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Acronym	A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Scientific Title	A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Scientific Title:Acronym	A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Region	Japan

Condition
Condition	Repsratory Syncytial virus: RSV
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A study of the efficacy of pranlukast hydrate for infant patients with acute wheezing caused by RS virus infection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluate whether internal use of pranlukast from an early stage after hospitalization contributes to the reduction of symptom within onset one month in children hospitalized with acute wheezing caused by RS virus infection.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In intervention group, PO 7mg/kg per day as pranlukast hydrate, in 2 divided doses for 28days in addition to supportive care as usual
Interventions/Control_2	In control group, supportive care as usual
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	1 months-old <
Age-upper limit	24 months-old >
Gender	Male and Female
Key inclusion criteria	Children hospitalized with RSV bronchiolitis
Key exclusion criteria	Children with comorbidity
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Yoshiaki Middle name Last name Sato
Organization	Nagoya University Hospital
Division name	Centor for Maternal-Neonatal Care
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-741-2111
Email	yoshiaki@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Suguru Middle name Last name Takeuchi
Organization	Nagoya University Graduate School of Medicine
Division name	Pediatrics/Developmental pediatrics
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-741-2111
Homepage URL
Email	suguru-t@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Nagoya University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Nagoya University Graduate School of Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel	052-741-2111
Email	ethics@med.nagoya-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 11 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	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 01 Day
Date of IRB	2017 Year 05 Month 18 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 10 Day
Last modified on	2019 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028748