UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of patient satisfaction to Second-generation antihistamines in the treatment of Japanese cedar and cypress family pollinosis.
Title of the study (Brief title)	Investigation of patient satisfaction in pollinosis to antihistamines.
Region	Japan

Condition
Condition	Japanese cedar and cypress family pollinosis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The distribution medicine is administered to two groups "Medicine of which the feature is height in the effect" and "Medicine that assumes few of drowsiness to be a feature" by the patient's hope for the pollinosis patient, and the influence and the patient satisfaction are investigated on the effect and QOL.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Transitions of nasal symptom and ocular condition of two weeks after beginning of the treatment from first medical examination
Key secondary outcomes	Symptom score (stuffy nose,runny nose, sneezing,eye itchiness and tearing), medication score and QOL Questionaire score(JRQLQ No1). Satisfaction rating to treatment.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	From the first medical examination, administer 5 mg as olopatadine hydrochloride twice a day orally in the morning and at bedtime , at least two weeks.
Interventions/Control_2	From the first medical examination, administer 60 mg as fexofenadine hydrochloride twice a day orally , at least two 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	(1) It is pollinosis caused by Japanese cedar or cypress pollen and a final diagnosis is a done patient. (2) Patient judged that severity of symptoms when beginning to investigate is more than slight illness based on risk stratification of "Practical Guideline for the Management of Allergic Rhinitis in Japan(2009)" (3) Written informed consent is required.
Key exclusion criteria	(1) with nasal diseases such as nasal polyps, hypertrophic rhinitis, acute chronic rhinitis, or deviated septum which cause a barrier to evaluate nasal symptoms. (2) Patient that change of symptom is remarkable after specific immunotherapy is begun. (3) Patient who should continuously use medicine (antiallergic drugs, antihistamine drugs, anticholinergic drugs, a complex of histamine/ Gamma-globulin preparations, vasoconstrictor drugs and antihypertensive drugs) that influences when effect of drug evaluation. (5) Pregnancy, potential pregnancy, and breast-feeding patient. (6) the others, inappropriate to this study by the judgment of doctor.
Target sample size	300

Research contact person
Name of lead principal investigator	Eriko Hoshi
Organization	Shiga University of Medical Science
Division name	Department of Otorhinolaryngology
Address	Seta Tsukinowa-cho, Otsu City, Shiga, JAPAN
TEL	077-541-2261
Email

Public contact
Name of contact person
Organization	Shiga University of Medical Science
Division name	Department of Otorhinolaryngology
Address
TEL	077-541-2261
Homepage URL
Email

Sponsor
Institute	Department of Otorhinolaryngology , Shiga University of Medical Science
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2010 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 01 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2010 Year 05 Month 01 Day
Date of closure to data entry	2016 Year 08 Month 29 Day
Date trial data considered complete	2016 Year 08 Month 29 Day
Date analysis concluded	2016 Year 08 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 02 Month 02 Day
Last modified on	2016 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003796