UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029379 |
|---|---|
| Receipt number | R000033576 |
| Scientific Title | Rapid effect of Flutiform on pulmonary function compared with Relvar and Symbicort |
| Date of disclosure of the study information | 2017/10/02 |
| Last modified on | 2018/03/05 23:55:35 |
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Basic information
Public title
Rapid effect of Flutiform on pulmonary function compared with Relvar and Symbicort
Acronym
Rapid effect of Flutiform on pulmonary function compared with Relvar and Symbicort
Scientific Title
Rapid effect of Flutiform on pulmonary function compared with Relvar and Symbicort
Scientific Title:Acronym
Rapid effect of Flutiform on pulmonary function compared with Relvar and Symbicort
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the rapid onset of Flutiform with Relvar and Symbicort with pulmonary function test.
Basic objectives2
Others
Basic objectives -Others
Mean change of post-dose FEV1 from pre-dose FEV1 (3 minutes after inhalation)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change of FEV1 from pre-dose FEV1 (3 minutes after inhalation)
Key secondary outcomes
1) Pulmonary function parameters
Measured value at each evaluation point
-Amount of change, change rate from pre-dose
-AUC (change of amount from pre-dose)
2) Asthma control level
-ACQ score
-JACS score
-Correlation between JACS and ACQ
3) Adverse Events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single dose of Flutiform 125 Aerosol 2 puffs
Interventions/Control_2
Single dose of Symbicort Turbohaler 2 inhalations
Interventions/Control_3
Single dose of Relvar Ellipta single inhalationt
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
<Visit 0>
(1) Patients who were diagnosed as bronchial asthma.
(2) Men or women aged >=20 and <80 years on the date of consent.
(3) Patients who are able to change ICS/LABA to ICS with same titer.
(4) Patients who are able to visit in the morning.
(5) Patients who can voluntary provide consent with sufficient understanding of participation.
<Visit 1>
(1) Patients who provide consent based on the informed consent document.
(2) Patients whose severity of asthma were mild persistent or moderate persistent by JGL2015.
(3) Patients who were step 2 or 3 by JGL2015.
(4) Patients' symptoms in current treatment are "Controlled" or "Mild intermittent".
(5) ACQ <= 0.75.
(6) No asthma exacerbation during three months.
Key exclusion criteria
<Visit 1>
(1) Obvious COPD, ACO.
(2) >=10 pack-years.
(3) Patients who are not able to operate inhaler device.
(4) Patients who used ICS/LABA or changed the dose of ICS during Run-in period.
(5) Patients who inhaled Flutide Diskus before visit.
(6) Chronic airway infection.
(7) Patients who are complicated with severe liver, kidney and heart disease.
(8) Patients who merger malignant tumor.
(9) Patients who are pregnant or are likely to be pregnant.
(10) Patients who are inadequate as the study subjects.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
Tohno Chuo Clinic
Division name
Respiratory medicine
Zip code
Address
14-1, Matsugase-cho, 1-Chome, Mizunami-shi, Gifu, Japan
TEL
0572-67-1118
aims_reserve@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
Tohno Chuo Clinic
Division name
Respiratory medicine
Zip code
Address
14-1, Matsugase-cho, 1-Chome, Mizunami-shi, Gifu, Japan
TEL
0572-67-1118
Homepage URL
aims_reserve@yahoo.co.jp
Sponsor or person
Institute
Tohno Chuo Clinic
Institute
Department
Personal name
Funding Source
Organization
Kyorin pharmaceutical co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
東濃中央クリニック/Tohno Chuo Clinic
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 02 | 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
| 2017 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 02 | Day |
Last modified on
| 2018 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033576
