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

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 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


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

Value
https://center6.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