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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029379
Receipt No. 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

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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
Email 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
Email aims_reserve@yahoo.co.jp

Sponsor
Institute Tohno Chuo Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033576

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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