UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009647 |
|---|---|
| Receipt number | R000005257 |
| Scientific Title | Efficacy of treatments for Japanese cedar pollinosis based on guideline -combined treatment ofleukotriene receptor antagonist with H1 receptor antagonists |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2013/02/11 14:35:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of treatments for Japanese cedar pollinosis based on guideline -combined treatment ofleukotriene receptor antagonist with H1 receptor antagonists
Acronym
Combined treatment of LTRA with H1RA
Scientific Title
Efficacy of treatments for Japanese cedar pollinosis based on guideline -combined treatment ofleukotriene receptor antagonist with H1 receptor antagonists
Scientific Title:Acronym
Combined treatment of LTRA with H1RA
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of treatment for Japanese cedar pollinosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms and QOL
Key secondary outcomes
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
intranasal corticosteroid
Interventions/Control_2
antihistamine
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with Japanese ceadr pollinosis haveing symptoms at least 2 seasons.
Key exclusion criteria
(1) concomitant sinonasal disease that could potentially affect the outcome of the trial (e.g., nasal polyps, rhinosinusitis, nasal septum deviation); (2) concomitant treatment for AR caused by allergens other than Japanese cedar/cypress pollen; (3) rhinitis medicamentosa and non-infectious, non-allergic rhinitis; (4) medication with anti-allergic drugs including H1RA, chromones, glucocorticoids and decongestants within 2 weeks of study initiation; (5) cedar pollen-specific immunotherapy; (6) sinonasal surgery including laser vaporization of inferior turbinates within 6 months;(7) concomittant uncontrolled asthma (8) hypersensitivity to INS and H1RA (9)systemic infection including mycosis; or (10) were pregnant and breastfeeding.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Okano |
Organization
Okayama University School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Otolaryngology Head and Neck Suergery
Zip code
Address
2-5-1 Shikatacho, Okayama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama University School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Otolaryngology Head and Neck Suergery
Zip code
Address
TEL
086-235-7307
Homepage URL
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 27 | Day |
Last modified on
| 2013 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005257
