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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016856
Receipt No. R000019568
Scientific Title Evaluation of the clinical efficacy of flutiform®(fluticasone propionate /formoterol fumarate) on severe persistent bronchial asthma
Date of disclosure of the study information 2015/03/20
Last modified on 2016/04/04

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Basic information
Public title Evaluation of the clinical efficacy of flutiform®(fluticasone propionate /formoterol fumarate) on severe persistent bronchial asthma
Acronym Evaluation of the clinical efficacy of flutiform®(fluticasone propionate /formoterol fumarate) on severe persistent bronchial asthma
Scientific Title Evaluation of the clinical efficacy of flutiform®(fluticasone propionate /formoterol fumarate) on severe persistent bronchial asthma
Scientific Title:Acronym Evaluation of the clinical efficacy of flutiform®(fluticasone propionate /formoterol fumarate) on severe persistent bronchial asthma
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effects of high doses of Flutiform will be investigated in a comparison with high doses of conventional treatments on patients with severe persistent asthma which is not well controlled with medium doses of ICS/LABA (dry powders).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Asthma control questionnaire (ACQ)
Key secondary outcomes Pulmonary function tests (FEV1, %FEV1, FEV1%, V25, V50), FeNO, IOS indices (R5, R20, R5-R20, X5, Ax), the number of times rescue medications are used (oral steroids, infusion (steroids/aminophylline), SABA)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 <Observation period> Medium dose of ICS/LABA combination (dry powders) for 4 weeks
<Treatment period> High dose of Flutiform&reg; (4 puff twice daily) for 8 weeks
Interventions/Control_2 <Observation period> Medium dose of ICS/LABA combination (dry powders) for 4 weeks
<Treatment period> High of pretreatment drug for 8 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria <Observation period>
(1) Adult patients with asthma
(2) Outpatients
(3) Those who are receiving Step-3 treatment in accordance with the "asthma prevention and management guideline 2012 (JGL2012)"
(4) Those who have been treated with ICS/LABA (medium doses, DPI formulation) for more than 4 weeks
(5) Patients with severe persistent asthma according to the "severity classification based on current treatment" of the JGL2012
(6) Those who understand an explanation about the present study and can give written informed consent
*Those who fulfill the inclusion criteria above and have been treated without a dose change during the 4 weeks before informed consent are allowed to immediately enter the treatment period.
<Treatment period>
Those who fulfill the criteria below at the end of the observation period can enter the treatment period.
(1) Those who are receiving Step-3 treatment in accordance with the JGL2012
(2) Patients with severe persistent asthma according to the "severity classification based on current treatment" of the JGL2012
(3) Those who were treated without a dose change during the observation period
Key exclusion criteria (1) Patients with COPD
(2) Patients who take SABA other than treatment of exacerbations
(3) Patients who had a history of adverse reaction to ICS or LABA
(4) Patients who took flutiform &reg; within four weeks
(5) Patients with severe cardiac, hepatic, renal, pulmonary, or hematologic disease
(6) Current malignancy
(7) Smoking within past 1 year
(8) Those who are pregnant, under-lactation, or desire pregnancy
(9) Unsuitability as determined by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Ishii
Organization Dokkyo Medical University Hospital
Division name Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address 880, Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL 0282-87-2151
Email ishiiysk@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mori Nobuhide
Organization Research Administration Office (Mebix, Inc.)
Division name Research Promotion Office
Zip code
Address Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, 107-0052, Japan
TEL 03-4362-4504
Homepage URL
Email flutiform@mebix.co.jp

Sponsor
Institute Dokkyo Medical University Hospital
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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 20 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
2015 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 23 Day
Last follow-up date
2016 Year 01 Month 05 Day
Date of closure to data entry
2016 Year 02 Month 29 Day
Date trial data considered complete
2016 Year 03 Month 15 Day
Date analysis concluded
2016 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 20 Day
Last modified on
2016 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019568

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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