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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010829
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Keio University School of Medicine, Department of Otolaryngology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012683

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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