UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study on clinical efficacy of anti-allergic medical therapy and nitric oxide levels in patients with allergic rhinitis.
Title of the study (Brief title)	Clinical efficacy of anti-allergic medical therapy and nitric oxide levels in patients with allergic rhinitis.
Region	Japan

Condition
Condition	allergic rhinitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine the clinical efficacy of medical therapy and exhaled NO levels in patients with allergic rhinitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	subjective symptoms and clinical findings
Key secondary outcomes	nitric oxide levels

Base
Study type

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Medical treatment in AR patients with moderate symptoms for 8 weeks.
Interventions/Control_2	Medical treatment in AR patients with severe symptoms for 8 weeks.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	symptomatic allergic rhinitis patients
Key exclusion criteria	patients with other systemic diseases who fail to participate in the treatment schedule pregnant patients patients with previous sinus surgery
Target sample size	110

Research contact person
Name of lead principal investigator	Katsuhiro Hirakawa
Organization	Hiroshima University
Division name	Department of Otorhinolaryngology
Address	Kasumi 1-2-3, Minami-ku, Hiroshima
TEL	082-257-5252
Email	jibi@hiroshima-u.ac.jp

Public contact
Name of contact person	Sachio Takeno
Organization	Hiroshima University
Division name	Department of Otorhinolaryngology
Address	Kasumi 1-2-3, Minami-ku, Hiroshima
TEL	082-257-5252
Homepage URL
Email	takeno@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	Department of Otorhinolaryngology, Hiroshima University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 14 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016069