UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021822 |
|---|---|
| Receipt number | R000025109 |
| Scientific Title | Study of the effect of the exhale through the nose method by Inhaled corticosteroid and Long Acting Beta2 Agonist (ICS / LABA) combination drug in patients with asthma merger sinusitis |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2018/11/25 15:39:50 |
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Basic information
Public title
Study of the effect of the exhale through the nose method by Inhaled corticosteroid and Long Acting Beta2 Agonist (ICS / LABA) combination drug in patients with asthma merger sinusitis
Acronym
Study of the effect of the exhale through the nose method by ICS / LABA combination drug in patients with asthma merger sinusitis
Scientific Title
Study of the effect of the exhale through the nose method by Inhaled corticosteroid and Long Acting Beta2 Agonist (ICS / LABA) combination drug in patients with asthma merger sinusitis
Scientific Title:Acronym
Study of the effect of the exhale through the nose method by ICS / LABA combination drug in patients with asthma merger sinusitis
Region
| Japan |
Condition
Condition
Asthma
Sinusitis
Eosinophilic sinusitis
Classification by specialty
| Pneumology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients asthma merger sinusitis, to examine the efficacy and safety of the Inhaled by exhale through the nose method Inhaled corticosteroid and Long Acting Beta2 Agonist combination drug
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the Lund-Mackey staging system CT scoring three months after the intervention
Key secondary outcomes
Rhinosinusitis endoscopic findings, eosinophils in nasal discharge, respiratory function tests, FeNO, IL-4, IL-5, IL-10, INF-gamma, ECP, peripheral blood eosinophil count, non-specific IgE quantitation, SNOT-22 (Sino-Nasal Outcome Test-22), ACT (Asthma Control Test)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
exhale through the nose method Fluticasone propionate / formoterol fumarate combination(:FFC) drug
Inhaled by exhale through the nose method twice a day 2 times per once.
Between three months.
Interventions/Control_2
Inhalation Fluticasone propionate / formoterol fumarate combination(:FFC) drug
Inhaled twice a day 2 times per once.
Between three months.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
There are nasal symptoms in a person who has been diagnosed with asthma by a respiratory physician, who the existence of sinusitis in the paranasal sinuses CT has been confirmed.
Who can stop using a combination banned drug during a given period and test period of the previous inspection.
Key exclusion criteria
1)Those who in this study implementation period is scheduled to surgery for sinusitis
2)A person who has a history that is considered to have an impact on the evaluation of the study (drug abuse, dependence, alcohol abuse, dependence, digestive, heart, liver, lung, eye, blood diseases, etc.)
3)person of corticosteroids, while taking cromolyn sodium (oral oral medicine, nasal drops is not allowed)
4)those who are taking anti-histamines
5)Those who are receiving immunotherapy, including desensitization therapy
6)pregnant women, breast-feeding women
7)current smokers, non smoking duration a person of less than one year
8)Those who can not properly enforce the respiratory function test
9)Other, who is determined to be ineligible as a subject of the present study than test doctor
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIRANO KOJIRO |
Organization
Showa University Koto Toyosu Hospital
Division name
Department of Otorhinolaryngology
Zip code
Address
5-1-38, Toyosu, Koto-ku, Tokyo, 135-8577, Japan
TEL
03-6204-6000
hirano.yasu@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIRANO KOJIRO |
Organization
Showa University Koto Toyosu Hospital
Division name
Department of Otorhinolaryngology
Zip code
Address
5-1-38, Toyosu, Koto-ku, Tokyo, 135-8577, Japan
TEL
03-6204-6000
Homepage URL
hirano.yasu@hotmail.co.jp
Sponsor or person
Institute
Department of Otorhinolaryngology Showa University Koto Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Otorhinolaryngology Showa University Koto Toyosu Hospital
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
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
昭和大学江東豊洲病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 10 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 10 | 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 | 04 | Month | 07 | Day |
Last modified on
| 2018 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025109
