UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of regular and as-needed use of Mometasone furoate hydrate nasal spray in the treatment of Japanese cedar pollinosis
Acronym	Mometasone furoate hydrate nasal spray for pollinosis: regular versus as-needed use
Scientific Title	A comparison of regular and as-needed use of Mometasone furoate hydrate nasal spray in the treatment of Japanese cedar pollinosis
Scientific Title:Acronym	Mometasone furoate hydrate nasal spray for pollinosis: regular versus as-needed use
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effectiveness of regular and as-needed use of Mometasone furoate hydrate nasal spray for Japanese cedar pollinosis with the disease specific quality of life questionnaire.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Overall quality of life score of Rhinoconjunctivitis Quality of Life Questionnire.
Key secondary outcomes	1) Each score of seven domains of RQLQ. 2) Two summary scores (PCS and MCS) of SF-36 v2. 3) Each severity score of four daily nasal symptoms (runny nose, itchy nose , stuffy nose, and sneezing). 4) Total nasal symptom score (the sum of four nasal symptom scores). 5) Each severity score of three daily ocular symptoms (eye itchiness, eye redness, and tearing). 6) Total ocular symptom score (the sum of three ocular symptom scores).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Regular use group: Taking two puffs of Mometasone furoate hydrate nasal spray into each nostril (total 200 ug/day) every morning from the onset of nasal symptoms.
Interventions/Control_2	As-needed use group: Taking two puffs of Mometasone furoate hydrate nasal spray into each nostril once a day (total 200 ug/day) in case of the patient having troublesome nasal symptoms.
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	16 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) A history of Japanese cedar pollinosis for at least one season before study entry. 2) Positive allergy skin test to Japanese cedar pollen or Japanese cedar pollen specific IgE RAST score >= class 2. 3) Written informed consent is required.
Key exclusion criteria	1) Taking any immunosuppressive drugs or systemic steroid drugs within six months before study entry. 2) Taking any antibiotics within two weeks before study entry. 3) Taking any anti-allergy drugs within two weeks before study entry. 4) Using any anti-allergy nasal drops within two weeks before study entry. 5) Under treatment of buildup phase of specific immunotherapy. 6) Patients with deflected nasal septum, sinusitis, or nasal polyps which cause a barrier to evaluate nasal symptoms. 7) Patients with upper respiratory inflammation, respiratory infection, or severe bronchial asthma. 8) Patients with severe cardiac, hepatic, kidney, or hematological disease. 9) A history of hypersensitivity to mometasone furoate hydrate, loratadine, or sodium cromoglycate. 10) Pregnant or lactating women and women who may be pregnant. 11) Taking a drug of erythromycin or cimetidine.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keisuke Masuyama
Organization	University of Yamanashi
Division name	Department of Otorhinolaryngology, Head & Neck Surgery
Zip code
Address	1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN
TEL	055-273-6769
Email	mkeisuke@yamanashi.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Goro Takahashi
Organization	University of Yamanashi
Division name	Department of Otorhinolaryngology, Head & Neck Surgery
Zip code
Address	1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN
TEL	055-273-6769
Homepage URL	http://www.yuent.umin.jp/kafun/
Email	tgoro@yamanashi.ac.jp

Sponsor
Institute	Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, University of Yamanashi
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2009 Year 01 Month 17 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
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	2008 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2009 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 01 Month 17 Day
Last modified on	2016 Year 02 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001976

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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