UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028765 |
|---|---|
| Receipt number | R000032919 |
| Scientific Title | Effect of Symbicort nasal exhalation for eosinophilic rhinosinusitis with bronchial asthma |
| Date of disclosure of the study information | 2017/08/23 |
| Last modified on | 2017/08/21 23:29:46 |
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Basic information
Public title
Effect of Symbicort nasal exhalation for eosinophilic
rhinosinusitis with bronchial asthma
Acronym
Nasal exhalation of Symbicort for ECRS with asthma
Scientific Title
Effect of Symbicort nasal exhalation for eosinophilic
rhinosinusitis with bronchial asthma
Scientific Title:Acronym
Nasal exhalation of Symbicort for ECRS with asthma
Region
| Japan |
Condition
Condition
eosinophilic rhinosinusitis
bronchial asthma
Classification by specialty
| Pneumology | Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with eosinophilic rhinosinusitis and bronchial asthma, to examine the efficacy of nasal exhalation of formoterol/budesonide combination dry powder after high flow-rate inhalation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of Lund-Mackay CT score three month after the intervention
Key secondary outcomes
%FEV1.0, %MMEF, percentage of peripheral blood eosinophil, Asthma Control Test (ACT), symptom scores of disturbance of smell and nasal obstruction
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nasal exhalation of budesonide/formoterol dry powder after inhalation with flow rate of 60L/min.
4puff twice a day
for three month
Interventions/Control_2
oral exhalation of budesonide/formoterol dry powder after inhalation with flow rate of 30-40L/min.
4puff twice a day
for three month
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
moderate to severe bronchial asthma with
eosinophilic rhinosinusitis (JESREC clinical score is 11 or more).
Who can stop prohibited medication for during the given period.
Key exclusion criteria
1) intranasal steroid, systemic corticosteroid, depo-triamcinolone, Shinni-Seihai Tou, mepolizumab are prescribed.
2)Systemic steroid prescribed twice or more within one month.
3)Omalizumab or LTRA is begun within 6 month.
4)Who has a complication considered to affect the evaluation of this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Yasuba |
Organization
Mitsubishi Kyoto Hospital
Division name
Allergy and pulmonary medicine
Zip code
Address
1 Gosho-tyou, Nisikyou-ku, Kyoto, 615-8087 Japan
TEL
075-381-2111
hyacchan@ga2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Yasuba |
Organization
Mitsubishi Kyoto Hospital
Division name
Allergy and pulmonary medicine
Zip code
Address
1 Gosho-tyou, Nisikyou-ku, Kyoto, 615-8087 Japan
TEL
075-381-2111
Homepage URL
hyacchan@ga2.so-net.ne.jp
Sponsor or person
Institute
Department of Allergy and pulmonary medicine,
Mitsubishi Kyoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Allergy and pulmonary medicine,
Mitsubishi Kyoto 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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 21 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032919
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
