UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010829 |
|---|---|
| Receipt number | R000012683 |
| Scientific Title | Effects of anti-allergic rhinitis treatment on adherence to nasal positive airway pressure therapy |
| Date of disclosure of the study information | 2013/05/29 |
| Last modified on | 2015/05/08 10:46:31 |
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Basic information
Public title
Effects of anti-allergic rhinitis treatment on adherence to nasal positive airway pressure therapy
Acronym
allegic rhinitis and nasal positive airway pressure therapy
Scientific Title
Effects of anti-allergic rhinitis treatment on adherence to nasal positive airway pressure therapy
Scientific Title:Acronym
allegic rhinitis and nasal positive airway pressure therapy
Region
| Japan |
Condition
Condition
obstructive sleep apnea syndrome
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of anti allergic medication on patients with sleep apnea syndrome (SAS) amd allegic rhinitis are investigated in terms of adherence to continuous positive airway pressure (CPAP) therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hours of using CPAP per day
Key secondary outcomes
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
administration of montelukast or loratadine
Interventions/Control_2
seasonal or chronic allergic rhinitis
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with sleep apnea syndrome treated by CPAP and comorbid allergic rhinitis
Key exclusion criteria
patients with nasal polyp or tumor
patients with a history of nose surgery within the past 3 years
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Ogawa |
Organization
keio University School of Medicine
Division name
Otolaryngology- head and neck surgery
Zip code
Address
35 Shinanomachi, Shinjuku
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Institutional Review Board
Zip code
Address
TEL
Homepage URL
http://www.ccr.med.keio.ac.jp/rinri/index.html
Sponsor or person
Institute
Keio University School of Medicine, Department of Otolaryngology
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
Organization
Division
Category of Funding Organization
Profit organization
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 | 05 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 29 | Day |
Last modified on
| 2015 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012683
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
