UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Fexofenadine/Pseudoephedrine combination tablet on Nasal Obstruction in Patients with Allergic Rhinitis
Acronym	Effect of Fexofenadine/Pseudoephedrine combination tablet on Nasal Obstruction in Patients with Allergic Rhinitis
Scientific Title	Effect of Fexofenadine/Pseudoephedrine combination tablet on Nasal Obstruction in Patients with Allergic Rhinitis
Scientific Title:Acronym	Effect of Fexofenadine/Pseudoephedrine combination tablet on Nasal Obstruction in Patients with Allergic Rhinitis
Region	Japan

Condition
Condition	allergic rhinitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we estimated the efficacy of fexofenadine/pseudoephedrine on nasal obstruction in patients with perennial allergic rhinitis versus fexofenadine using objective methods.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	nasal airflow
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	measure nasal airflow for 8 hours at 30-minute intervals after taking a single agent: fexofenadine/pseudoephedrine combination tablet
Interventions/Control_2	measure nasal airflow for 8 hours at 30-minute intervals after taking a single agent:fexofenadine
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) with a history of allergic rhinitis (2) with nasal obstruction (3) house dust mite allergy based on skin reactions or serum allergen-specific IgE antibody measurements.
Key exclusion criteria	(1) upper respiratory tract infection (2) allergen-specific immunotherapy (3) pregnancy, or lactation (4) patients with hypertension, severe asthma (5)a history of known hypersensitivity, allergic reactions
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiromi Middle name Last name Takeuchi
Organization	Tottori University
Division name	Division of Otolaryngology, Head and Neck Surgery, Department of Medicine of Sensory and Motor Organ
Zip code	683-8503
Address	36-1, Nishi-cho, Yonago
TEL	0859-38-6627
Email	oto3175@tottori-u.ac.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Nakamura
Organization	Faculty of Medicine, Tottori University
Division name	Division of Otolaryngology, Head and Neck Surgery, Department of Medicine of Sensory and Motor Organ
Zip code	683-8504
Address	36-1, Nishi-cho, Yonago
TEL	0859-38-6627
Homepage URL
Email	yosuken@tottori-u.ac.jp

Sponsor
Institute	Tottori University
Institute
Department

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	Faculity of Medicine,Tottori university
Address	36-1 Nishi-cho, Yonago
Tel	0859-38-7108
Email	me-kenkyu@ml.adm.tottori-u.ac.jp

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	2020 Year 09 Month 18 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	24
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	Main results already published
Date of protocol fixation	2013 Year 07 Month 08 Day
Date of IRB	2013 Year 07 Month 08 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 18 Day
Last modified on	2020 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047769