UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025040
Receipt No. R000028816
Scientific Title A randomized open-label positive-controlled crossover study of clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic rhinosinusitis
Date of disclosure of the study information 2017/01/01
Last modified on 2016/11/29

* 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 A randomized open-label positive-controlled crossover study of clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic rhinosinusitis
Acronym Clinical efficacy of different type of inhaler devices for asthmatics with ECRS
Scientific Title A randomized open-label positive-controlled crossover study of clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic rhinosinusitis
Scientific Title:Acronym Clinical efficacy of different type of inhaler devices for asthmatics with ECRS
Region
Japan

Condition
Condition asthma with eosinophilic chronic rhinosinusitis
Classification by specialty
Pneumology Clinical immunology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic chronic rhinosinusitis treated with inhaled corticosteroid exhalation through the nose
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Levels of fractionated exhaled nitrogen oxide 8 weeks after starting each trial drug administration
Key secondary outcomes Lung function, nasal polyp score and sinus CT score 8 weeks after starting each trial drug administration

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 Adair Discus 500 microgram one inhalation twice daily for 8 weeks, followed by Relvar Ellipta 200 microgram one inhalation once daily for 8 weeks
Interventions/Control_2 Relvar Ellipta 200 microgram one inhalation once daily for 8 weeks, followed by Adair Discus 500 microgram one inhalation twice daily for 8 weeks
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. patients with good asthma control under more than 8 weeks treatment with Adair Aerosol 250 microgram 2 inhalation twice daily though the nose
2. non-smoker
Key exclusion criteria 1. exacerbation within 4 weeks (eg. infection and asthma attack)
2. concomitant disease currently treated (eg. heart diseases, hematologic disorders, respiratory diseases)
3. pregnant patients
4. possibility of lack of examination security.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Kobayashi
Organization Kansai Medical University
Division name Department of Otolaryngology, Neck and head surgery
Zip code
Address 2-5-1 Shinmachi, Hirakata, Osaka
TEL 072-804-0101
Email kobayosh@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Kobayashi
Organization Kansai Medical University
Division name Department of Otolaryngology, Neck and head surgery
Zip code
Address 2-5-1 Shinmachi, Hirakata, Osaka
TEL 072-804-0101
Homepage URL
Email kobayosh@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical 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
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
2017 Year 01 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
2016 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 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
2016 Year 11 Month 29 Day
Last modified on
2016 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028816

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.