UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031039 |
|---|---|
| Receipt number | R000035450 |
| Scientific Title | Comparison of clinical efficacy between fluticasone propionate/ formoterol (FFC) and fluticasone furoate/ vilanterol (VFC) in patients with asthma |
| Date of disclosure of the study information | 2018/01/29 |
| Last modified on | 2020/09/14 10:20:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of clinical efficacy between fluticasone propionate/ formoterol (FFC) and fluticasone furoate/ vilanterol (VFC) in patients with asthma
Acronym
Comparison of clinical efficacy between FFC and VFC
Scientific Title
Comparison of clinical efficacy between fluticasone propionate/ formoterol (FFC) and fluticasone furoate/ vilanterol (VFC) in patients with asthma
Scientific Title:Acronym
Comparison of clinical efficacy between FFC and VFC
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical efficacy of fluticasone propionate/formoterol compared to fluticasone furoate/vilanterol in asthmatic patients insufficiently or poorly controlled by inhaled steroids.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Period until patients insufficiently or poorly controlled on ICS therapy are determined to be well-controlled by switching to ICS/LABA therapy
Evaluation at 24 Week visit
Key secondary outcomes
-Pulmonary functions
Evaluation at 0, 2, 8, 16, and 24 Week visit
-symptoms
During research period
-peak flow meter
During research period
<Control level>
-JGL
Evaluation at 0 and 24 Week visit
-ACQ
Evaluation at 0, 2, 8, 16, and 24 Week visit
-JACS
Evaluation at 0, 2, 8, 16, and 24 Week visit
-Simulation for the percentage of patients/period of time until patients become well-controlled using ACQ/JACS
Evaluation at 0, 2, 8, 16, and 24 Week visit
-Device operability questionnaire
Evaluation at 0 and 24 Week visit
-Correlation between control level and symptoms
-Control level (ACQ/JACS)
Evaluation at 0, 2, 8, 16, and 24 Week visit
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Flutiform (20 patients)
Brand name: Flutiform125 Aerosol
Moderate dose: 500 micrograms per day
Study Period: 24 weeks
Frequency: 2 inhalations per dose, 2 times per day
Interventions/Control_2
Relvar (20 patients)
Brand Name: Relvar200Ellipta
Moderate-High dose: 200 micrograms per day
Study Period: 24 weeks
Frequency: 1 inhalation per dose, 1 time per day
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
1. Patients diagnosed with bronchial asthma according to Japanese guideline for asthma (The Asthma Prevention and Management Guideline 2015)
2. Outpatients (men and women) at least 20 years of age who can give informed consent
3. Patients who have been using ICS monotherapy for at least 4 weeks prior to Visit 1, are insufficiently or poorly controlled on ICS monotherapy, and can switch to Flutiform or Relvar
4. Patients with severe persistent asthma and whose present treatment classifies as step 2 or step 3 according to the Asthma Prevention and Management Guideline 2015 (classification of asthma severity based on the present treatment)
5. Patients who are insufficiently or poorly controlled according to the Asthma Prevention and Management Guideline 2015
Key exclusion criteria
1. Patients with evident ACO or COPD comorbidities
2. Patients with antibiotic-resistant infections, deep mycosis, or tuberculosis disease
3. Patients who have been afflicted with a respiratory infection (viral infection) within 8 weeks prior to enrollment
4. Patients with a smoking history of at least 10 pack years
5. Patients who have experienced side effects from the use of ICS, LABA or the combined medications
6. Patients who have used systemic steroids within 4 weeks prior to enrollment
7. Patients with significant heart, liver, kidney disease or other clinically significant comorbidities
8. Patients who are pregnant, breastfeeding, or plan to become pregnant during the study period
9. Other patients who are judged unsuitable for inclusion by the investigators in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ikeda |
Organization
Ikeda Clinic
Division name
Director
Zip code
751-0856
Address
3-11-2 Ichinomiyacho, Shimonoseki, Yamaguchi Prefecture, Japan Postal Code: 751-0856
TEL
083-263-3311
kiikiiken@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ikeda |
Organization
Increase Co., Ltd.
Division name
Clinical Development Department
Zip code
160-0022
Address
2-12-8 shinjuku, shinjuku-ku, Tokyo
TEL
03-5312-5026
Homepage URL
jtsuchiya@sa-tt.co.jp
Sponsor or person
Institute
Ikeda Clinic
Institute
Department
Personal name
Funding Source
Organization
KYORIN Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
goshogaya
Address
1-6-1 maiduru,chuuou-ku,fukuoka city
Tel
092-739-8525
gosho_irb@yahoo.co.jp
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
| 2018 | Year | 01 | Month | 29 | 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
24
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 | 11 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 07 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 29 | Day |
Last modified on
| 2020 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035450
