UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016856 |
|---|---|
| Receipt number | 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 16:15:10 |
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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® (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 ® 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
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
flutiform@mebix.co.jp
Sponsor or person
Institute
Dokkyo Medical University Hospital
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019568
