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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006502
Receipt No. R000007708
Scientific Title The effect of combination therapy of fluticasone furoate nasal spray with levocetirizine hydrochloride in patients with Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber).
Date of disclosure of the study information 2011/10/07
Last modified on 2012/01/05

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Basic information
Public title The effect of combination therapy of fluticasone furoate nasal spray with levocetirizine hydrochloride in patients with Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber).
Acronym The effect of combination therapy of fluticasone furoate nasal spray with levocetirizine hydrochloride in patients with Japanese cedar pollinosis.
Scientific Title The effect of combination therapy of fluticasone furoate nasal spray with levocetirizine hydrochloride in patients with Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber).
Scientific Title:Acronym The effect of combination therapy of fluticasone furoate nasal spray with levocetirizine hydrochloride in patients with Japanese cedar pollinosis.
Region
Japan

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

Objectives
Narrative objectives1 To clarify effect of combination therapy of fluticasone furoate with levocetirizine hydrochloride on nasal symptoms of Japanese cedar pollen exposure in an artificial exposure chamber(OHIO Chamber).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cumulative incidence rate of nasal symptoms after 3hr-pollen exposure
Key secondary outcomes Nasal symptoms
Ocular symptoms
Oral-pharyngeal symptoms
Amount of nasal discharge
Number of sneezing

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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Subject takes levocetirizine hydrochloride 5mg and fluticasone furoate nasal spray 110 micro g. once a day at previous night of pollen exposure.
Interventions/Control_2 Subject takes levocetirizine hydrochloride 5mg and fluticasone furoate nasal spray placebo once a day at previous night of pollen exposure.
Interventions/Control_3 Subject takes levocetirizine hydrochloride placebo and fluticasone furoate nasal spray placebo once a day at previous night of pollen exposure.
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) CAP-RAST score against Japanese cedar pollen over class 2 within the last 2 years.
2) Patients who have typical seasonal allergic rhinitis symptoms for at least 2 years. The presence of moderate and more symptoms, subject with main symptom of nasal congestion.
3) Written informed consent is required.
Key exclusion criteria 1) A hisotry of nasal and/or ocular disease
2) Evidence of upper and/or lower respiratory tract inflammation within 2 weeks prior to IC
3) An episode of sinusitis within 30 days prior to IC
4) A hisotry of treatment with steroid injection within 6 months prior to IC
5) A hisotry of treatment with steroid (oral and topical) within 4 weeks prior to IC
6) A history of asthma (include of child asthma)
7) A history of anaphylaxis
8) Patients who have the hypersensitivity to study drugs
9) Patients with desensitization therapy
10) Patients with nasal anatomical deformities leading to obstruction within 1 year prior to IC
11) Patients with cardiac, renal disease, or hepatic insufficiency
12) Pregnancy, breast-feeding woman, potencial pregnancy, patient who wish to become pregnant during this study
13) Patients who were judged to be unsuitable for patient enrollment by the doctor







Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimihiro Okubo
Organization Nippon Medical School
Division name Department of Otorhinolaryngology and Head /Neck Surgery
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku Tokyo 113-8603, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiyochika Suematsu
Organization Medical Corporation Shinanokai, Samoncho Clinic
Division name Pharmaceutical Dept.,
Zip code
Address Yotsuya Medical Bldg., 20, Samon-cho, Shinjuku-ku, Tokyo, 160-0017, Japan
TEL 03-5366-3641
Homepage URL
Email ki-suematsu@samoncho-clinic.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization The incorporated non-profit organization
Clinical Research Support Center Kyusyu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

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 医療法人社団信濃会 左門町クリニック

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 07 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 Completed
Date of protocol fixation
2011 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2011 Year 12 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
2011 Year 10 Month 07 Day
Last modified on
2012 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007708

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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