UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018619
Receipt number R000021546
Scientific Title Research on markers for omalizumab therapy in asthma
Date of disclosure of the study information 2015/08/11
Last modified on 2022/06/01 15:57:20

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Basic information

Public title

Research on markers for omalizumab therapy in asthma

Acronym

Research on markers for omalizumab therapy in asthma

Scientific Title

Research on markers for omalizumab therapy in asthma

Scientific Title:Acronym

Research on markers for omalizumab therapy in asthma

Region

Japan


Condition

Condition

asthma

Classification by specialty

Medicine in general Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To find markers for Omalizumab therapy.

Basic objectives2

Others

Basic objectives -Others

To find markers for Omalizumab therapy.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between clinical outcomes and biomarkers.

Key secondary outcomes



Base

Study type

Observational


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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients planned to use omalizumab.

Key exclusion criteria

Patients without researcher's assent.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Maho
Middle name
Last name Suzukawa

Organization

National Hospital Organization, Tokyo National Hospital

Division name

Clinical Research Center

Zip code

204-8585

Address

3-1-1 Takeoka, Kiyose-City, Tokyo 204-8585

TEL

0424912111

Email

fueta-tky@umin.ac.jp


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Konno

Organization

National Hospital Organization Tokyo National Hospital

Division name

Clinical Research Center

Zip code

204-8585

Address

3-1-1 Takeoka, Kiyose-City, Tokyo 204-8585

TEL

0424912111

Homepage URL


Email

fueta-tky@umin.ac.jp


Sponsor or person

Institute

National Hospital Organization, Tokyo National Hospital
Clinical Research Center

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization

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

National Hospital Organization Tokyo National Hospital

Address

3-1-1 Takeoka, Kiyose, Tokyo, Japan

Tel

0424912111

Email

fueta-tky@umin.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

184

Org. issuing International ID_1

Ethics Committee of Tokyo National Hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 11 Day


Related information

URL releasing protocol

https://www.resmedjournal.com/article/S0954-6111(17)30413-4/fulltext

Publication of results

Published


Result

URL related to results and publications

https://www.resmedjournal.com/article/S0954-6111(17)30413-4/fulltext

Number of participants that the trial has enrolled

31

Results

GETE assessment showed 19 responders (61.3%) and 12 non-responders (38.7%). Responders showed significantly higher levels of CXCL10 and IL-12 at baseline compared to non-responders . ROC curves to distinguish responders from non-responders using the baseline serum CXCL10 level showed a good AUC of 0.83. At 32 weeks of omalizumab therapy, serum CXCL10 tended to be increased and serum IL-12 tended to be decreased . On the other hand, serum IL-5 and PDGF were significantly decreased .

Results date posted

2022 Year 06 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Thirty-one patients with severe, persistent asthma were enrolled in this study and administered omalizumab for at least 1 year.

Participant flow

Response to omalizumab was assessed based on the physician's global evaluation of treatment effectiveness (GETE) at 48 weeks of treatment. Blood samples were collected at baseline and 16 and 32 weeks after starting omalizumab and measured for 30 cytokines by Luminex 200 and ELISA. Exhaled nitric oxide (FeNO) levels, peripheral blood eosinophil counts, pre-bronchodilator pulmonary functions and Asthma Quality of Life Questionnaire scores were determined at baseline and 16, 32 and 48 weeks after starting omalizumab. The numbers of clinically significant asthma exacerbations in the previous year and during 48 weeks of treatment with omalizumab were assessed.

Adverse events

N.A.

Outcome measures

Response to omalizumab was assessed based on the physician's global evaluation of treatment effectiveness (GETE) at 48 weeks of treatment.
FeNO levels, eosinophil counts, pulmonary functions, AQLQ, serum cytokine levels, and asthma exacerbations were compared at baseline and 16, 32 and 48 weeks after starting omalizumab.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 06 Month 26 Day

Date of IRB

2013 Year 06 Month 26 Day

Anticipated trial start date

2013 Year 06 Month 26 Day

Last follow-up date

2015 Year 06 Month 25 Day

Date of closure to data entry


Date trial data considered complete

2015 Year 12 Month 14 Day

Date analysis concluded



Other

Other related information

Case control observational study

All patients who met criteria for this study will be enrolled.

Data collection: pulmonary function tests, blood eosinophils, serum immunoglobulins and cytokines.


Management information

Registered date

2015 Year 08 Month 10 Day

Last modified on

2022 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021546


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name