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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018777
Receipt No. 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

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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
Institute Sagamihara National Hospital
Institute
Department

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
URL(English) https://upload.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


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