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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018038
Receipt No. R000019325
Scientific Title Investigation of clinical effects of treatment with fine particle inhaled corticosteroids exhalation through the nose
Date of disclosure of the study information 2015/07/01
Last modified on 2020/02/20

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Basic information
Public title Investigation of clinical effects of treatment with fine particle inhaled corticosteroids exhalation through the nose
Acronym Clinical effects of treatment with ICS exhalation through the nose
Scientific Title Investigation of clinical effects of treatment with fine particle inhaled corticosteroids exhalation through the nose
Scientific Title:Acronym Clinical effects of treatment with ICS exhalation through the nose
Region
Japan

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

Objectives
Narrative objectives1 To investigation of clinical effects of fine particle inhaled corticosteroids exhalation through the nose in patients with eosinophilic chronic rhinosinusitis with asthma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SInus CT findings before and after treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 fine particle inhaled corticosteroids exhalation through the nose: HFA-BDP (800 microgram per day) for 4 weeks
Interventions/Control_2 fine particle inhaled placebo exhalation through the nose: practice inhaler (8 doses per day) for 4 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 Patients with eosinophilic chronic rhinosinusitis with asthma who are scheduled for endoscopic sinus surgery
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 60

Research contact person
Name of lead principal investigator
1st name Yoshiki
Middle name
Last name Kobayashi
Organization Kansai Medical University
Division name Department of otolaryngology
Zip code 573-1010
Address 2-5-1 Shinmachi, Hirakata, Osaka
TEL 072-804-2463
Email kobayosh@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name Chikako
Middle name
Last name Yasuoka
Organization Kansai Medical University
Division name Research Devision
Zip code 573-1010
Address 2-5-1 Shinmachi, Hirakata, Osaka
TEL 072-804-2291
Homepage URL
Email kenkyu@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Kansai Medical University
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 Ethics committee, Kansai Medical University
Address 2-5-1 Shinmachi, Hirakata, Osaka
Tel 072-804-2291
Email kenkyu@hirakata.kmu.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
2015 Year 07 Month 01 Day

Related information
URL releasing protocol doi: 10.3389/fimmu.2018.02192
Publication of results Unpublished

Result
URL related to results and publications doi: 10.3389/fimmu.2018.02192
Number of participants that the trial has enrolled 23
Results
HFA-BDP MDI ETN treatment improved all assessed clinica
l endpoints and corticosteroid sensitivity without any deter
ioration in pulmonary function. FENO and blood eosinophil
number were reduced by HFA-BDP MDI ETN treatment.
Results date posted
2020 Year 02 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-three patients with severe ECRS under refractory t
o intranasal corticosteroid treatment
Participant flow
Patients were randomized in a double-blind fashion to rece
ive either HFA-BDP MDI ETN (n = 11) or placebo MDI ETN (
n = 12).
Adverse events
None
Outcome measures
Changes in nasal polyp score, sinus computed tomographi
c (CT) score, smell test, and QOL score from baseline were
assessed. FENO was measured as a marker of eosinophili
c airway inflammation. Response to corticosteroids was ev
aluated before and after treatment.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 03 Month 01 Day
Date of IRB
2015 Year 04 Month 30 Day
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2018 Year 03 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
2015 Year 06 Month 23 Day
Last modified on
2020 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019325

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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