UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028977
Receipt number R000033153
Scientific Title Safety and efficacy in patients with uncontrolled asthma: systemitic review and meta-analysis
Date of disclosure of the study information 2017/09/04
Last modified on 2017/09/03 08:40:41

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Basic information

Public title

Safety and efficacy in patients with uncontrolled asthma: systemitic review and meta-analysis

Acronym

Anti-IL-13 therapies in uncontrolled asthma

Scientific Title

Safety and efficacy in patients with uncontrolled asthma: systemitic review and meta-analysis

Scientific Title:Acronym

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

1st name
Middle name
Last name koichi ando

Organization

Showa University

Division name

Division of Respiratory Medicine and Allergology, Department of Medicine

Zip code


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

1st name
Middle name
Last name Showa University

Organization

Showa University

Division name

Division of Respiratory Medicine and Allergology, Department of Medicine

Zip code


Address

Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, Japan

TEL

+81-3784-8532

Homepage URL


Email

koichi-a@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 04 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

Completed

Date of protocol fixation

2017 Year 08 Month 03 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033153


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name