UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000021562