UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030466
Receipt No. R000034785
Scientific Title Identification of prediction marker for efficacy of anti-IL-5 antibody and observation of time course of biomarkers in asthma.
Date of disclosure of the study information 2017/12/19
Last modified on 2017/12/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Identification of prediction marker for efficacy of anti-IL-5 antibody and observation of time course of biomarkers in asthma.
Acronym iPOT-5 study: anti-iL-5 Ab: Prediction of efficacy and Observation of Time course of biomarkers
Scientific Title Identification of prediction marker for efficacy of anti-IL-5 antibody and observation of time course of biomarkers in asthma.
Scientific Title:Acronym iPOT-5 study: anti-iL-5 Ab: Prediction of efficacy and Observation of Time course of biomarkers
Region
Japan

Condition
Condition Asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Anti-IL-5 antibody (Ab) has been approved for molecular targeted therapy for asthma. Previous studies consistently showed that anti-IL-5 Ab suppressed the frequency of exacerbation and blood eosinophil count was identified as an important marker for prediction of efficacy. Although, asthma symptom or pulmonary function was not consistently improved by treatment and prediction markers for those index have not been established yet.
The aim of this study is to establish prediction marker for improvement in symptom or pulmonary function. To do this, we analyze the relationship between potential biomarkers other than eosinophils and improvement in symptom or pulmonary function.
In addition, we will also analyze, 1) the efficacy for chronic rhinosinusitis with nasal polyps, 2) the efficacy for reversibility negative patients, who was excluded in previous clinical trials, and 3) precise time course of various clinical index and biomarkers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes The relationship between the levels of candidate biomarkers and improvement in symptom after 32 w treatment.
Key secondary outcomes 1) Divide patients into two groups based on median value of pre-dose biomarkers and compare the effect on ACQ-5 score, exacerbation, and FEV1.
2) Relationship between early change (4 to 12 weeks after first injection) in clinical index and final improvement in ACQ-5 score or exacerbation after 32 weeks.
3) Precise time course of various biomarkers.
4) Effect on rhinosinusitis, atopic dermatitis, and otitis media.
5) Comparison of effect between reversibility positive and negative patients, or, patient with smoking history >= and < 10 pack year.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 mepolizumab
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Treated by >= 400 microg/day of inhaled corticosteroids (fluticasone equivalent) with one or more controllers (LABA, LTRA, or theophylline) for more than 3 months
2. Blood eosinophil counts >= 300/microl in previous 12 month or >= 150/microl at first injection
3. Exacerbation history (>=1) in previous 12 month
4. ACQ 5 score >= 0.75
Key exclusion criteria 1. Complicated by pulmonary disease other than asthma
2. Complicated by malignant diseases
3. Diagnosed as hypereosinophilc syndrome or eosinophilic granulomatosis with polyangiitis
4. Administrated omalizumab in previous 30 days
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Nagase, Yasuhiro Gon
Organization Teikyo University School of Medicine
Nihon University School of Medicine
Division name Department of Medicine, Department of Internal Medicine
Zip code
Address 1738605 Kaga 2-11-1, Itabashi-ku, Tokyo, Japan, 1738601 Oyaguchi kamicho 30-1, Itabashi-ku, Tokyo, Japan
TEL 81-3-3964-8351
Email nagaseh@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Nagase
Organization Teikyo University School of Medicine
Division name Department of Medicine
Zip code
Address 1738605 Kaga 2-11-1, Itabashi-ku, Tokyo, Japan
TEL 81-3-3964-8351
Homepage URL
Email nagaseh@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University School of Medicine
Nihon University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 NTT東日本関東病院 (東京都)、慶應義塾大学病院 (東京都)、順天堂大学医学部付属順天堂江東高齢者医療センター (東京都)、昭和大学病院 (東京都)、帝京大学医学部附属病院 (東京都)、東京女子医科大学病院 (東京都)、日本大学医学部附属板橋病院 (東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 19 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
2017 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 29 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 19 Day
Last modified on
2017 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034785

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.