UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018038 |
|---|---|
| Receipt number | 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 22:50:45 |
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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
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
kenkyu@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019325
