UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of sleep apnea syndrome with nasal obstruction
Title of the study (Brief title)	The study of nasal obstruction
Region	Japan

Condition
Condition	Sleep apnea syndrome
Classification by specialty	Pneumology Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Nasal obstruction frequently has been associated with worsening the treatment for sleep apnea syndrome(SAS). We examined the two types of treatment for allergic rhinitis with SAS, and in a future this study will be useful for nasal obstruction of SAS.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	1.The chages of nasal obstruction in patients with OSAS after treatment 2.Serum total IgE, RAST 3.The persistence of CPAP treatment (using time etc.) 4.The questionnaire of Pittsburg Sleep Quality Index(PSQI) 5.Epworth sleepness scale(ESS)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The following each treatment for 14days 1.Fexofenadine Hydrochloride(60mg) twice daily
Interventions/Control_2	2.Fexofenadine Hydrochloride(60mg)/ Pseudiephedrine Hydrochloride(120mg) Combination Tablets twice daily
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who diagnosed with SAS and started CPAP therapy have nasal obstruction for allergic rhinitis.
Key exclusion criteria	severe nasal septal space disease severe nasal polyps severe nasal tumor Uncontrolled hypertension Severe coronary artery disease Narrow angle glaucoma
Target sample size	100

Research contact person
Name of lead principal investigator	Koichi Fukunaga
Organization	Department of Medicine, Keio University School of Medicine
Division name	Pulmonary Medicine
Address	35 shinanomochi shinjyuku-ku, Tokyo, JAPAN
TEL	0333531211
Email	k-fuku@jf7.so-net.ne.jp

Public contact
Name of contact person	Wakako Yamasawa
Organization	Department of Medicine, Keio University School of Medicine
Division name	Pulmonary Medicine
Address	35 shinanomochi shinjyuku-ku, Tokyo, JAPAN
TEL	0333531211
Homepage URL	http://www.keio-med.jp/pulmonary/
Email	wakako@df6.so-net.ne.jp

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

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	no

Other related organizations
Co-sponsor	Nippon Koukan Hospital Kitasato University Kitasato Institute Hospital Shinjyuku Sleep Medical Clinic Kichijyoji Sleep Medical Clinic RESM Sleep Respiratory Medicalcareclinic
Name of secondary funｄer(s)

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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 27 Day
Anticipated trial start date	2013 Year 09 Month 27 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 02 Day
Last modified on	2017 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029836