UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018777
Receipt number R000021562
Scientific Title A randomized, double-blind, placebo-controlled, crossover study of the efficacy of omalizumab in patients with aspirin-exacerbated respiratory disease (AERD)
Date of disclosure of the study information 2015/08/24
Last modified on 2019/08/26 16:43:42

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Basic information

Public title

A randomized, double-blind, placebo-controlled, crossover study of the efficacy of omalizumab in patients with aspirin-exacerbated respiratory disease (AERD)

Acronym

The efficacy of omalizumab in AERD

Scientific Title

A randomized, double-blind, placebo-controlled, crossover study of the efficacy of omalizumab in patients with aspirin-exacerbated respiratory disease (AERD)

Scientific Title:Acronym

The efficacy of omalizumab in AERD

Region

Japan


Condition

Condition

Aspirin exacerbated respiratory disease (AERD)

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of omalizumab in patients with AERD

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in urinary concentration of leukotriene E4

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Period 1: Patients were treated with omalizumab for 3 months, followed by a washout interval of at least 18 weeks. Period 2: Patients were treated with placebo (saline) for 3 months.

Interventions/Control_2

Period 1: Patients were treated with placebo (saline) for 3 months, followed by a washout interval of at least 18 weeks. Period 2: Patients were treated with omalizumab for 3 months.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients diagnosed with AERD by a systemic aspirin provocation test within the last two years
2) At least one positive result in either a skin test or a serum-specific immunoglobulin E test for common environmental allergens
3) No previous treatment with omalizumab
4) Able to provide written, signed and dated informed consent

Key exclusion criteria

1) Previous treatment with omalizumab
2) Unable to provide written, signed and dated informed consent
3) Patients considered at risk of sinusitis and/or nasal polyp surgery during the study period
4) Patients with comorbidities (renal, hepatic, heart, mental, and malignancy) requiring treatment
5) Pregnancy, breast-feeding, or potential pregnancy
6) Patients considered unsuitable by the attending physician

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Masami
Middle name
Last name Taniguchi

Organization

Sagamihara National Hospital

Division name

Clinical Research Center for Allergy and Rheumatology

Zip code

2520392

Address

18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan

TEL

042-742-8311

Email

taniguchi.masami.ne@mail.hosp.go.jp


Public contact

Name of contact person

1st name Hiroaki
Middle name
Last name Hayashi

Organization

Sagamihara National Hospital

Division name

Clinical Research Center for Allergy and Rheumatology

Zip code

2520392

Address

18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan

TEL

042-742-8311

Homepage URL


Email

hayashi.hiroaki.kr@mail.hosp.go.jp


Sponsor or person

Institute

Sagamihara National Hospital

Institute

Department

Personal name



Funding Source

Organization

Labour Sciences Research Grant

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of the Organization Sagamihara National Hospital

Address

18-1 Sakuradai Minamiku Sagamihara Kanagawa

Tel

042-742-8311

Email

taniguchi.masami.ne@mail.hosp.go.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

国立病院機構相模原病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 24 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

16

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

No longer recruiting

Date of protocol fixation

2015 Year 08 Month 23 Day

Date of IRB

2014 Year 03 Month 18 Day

Anticipated trial start date

2015 Year 08 Month 24 Day

Last follow-up date

2017 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 23 Day

Last modified on

2019 Year 08 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021562


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name