UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy in patients with uncontrolled asthma: systemitic review and meta-analysis
Title of the study (Brief title)	Anti-IL-13 therapies in uncontrolled asthma
Region	Japan

Condition
Condition	uncontrolled asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and safety profiles between anti-IL-13 therapies and placebo in patients with uncontrolled asthma by performing a meta-analysis of RCTs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	chenge in FEV1.0 incidence of all adverse events
Key secondary outcomes	time to first asthma exacerbation change in ACQ score change in AQLQ

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	12 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	RCTs that assessed the clinical efficacy and safety of anti-IL-13 therapies in adolescents or adults aged 12 years or older with a diagnosis of uncontrolled, severe, or moderate to severeasthma; and studies whose outcomes included pulmonary function, any adverse event, asthma exacerbation, asthma control, or asthma related quality of life.
Key exclusion criteria	Observational, case-control, cohort, and non-blinded clinical trials were excluded.
Target sample size	1000

Research contact person
Name of lead principal investigator	koichi ando
Organization	Showa University
Division name	Division of Respiratory Medicine and Allergology, Department of Medicine
Address	Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, Japan
TEL	+81-3784-8532
Email	koichi-a@med.showa-u.ac.jp

Public contact
Name of contact person	Showa University
Organization	Showa University
Division name	Division of Respiratory Medicine and Allergology, Department of Medicine
Address	Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, Japan
TEL	+81-3784-8532
Homepage URL
Email	koichi-a@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	Showa University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 09 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 03 Day
Anticipated trial start date	2017 Year 08 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	pulmonary function was significantly improved in the anti-IL-13 group compared with the placebo group, and that there was no significant differences in the incidences of all adverse events between the anti-IL-13 group and the placebo group. These results suggest that anti-IL-13 therapies, are effective and generally well-tolerated in patients with uncontrolled asthma.

Management information
Registered date	2017 Year 09 Month 03 Day
Last modified on	2017 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033153