UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012327 |
|---|---|
| Receipt number | R000014412 |
| Scientific Title | A prospective, randomized, open-label parallel-group clinical study to investigate effects and maneuverability of devices of fluticasone/formoterol pMDI (Flutiform) vs. fluticasone/salmeterol DPI (Adoair Diskus) in patients who have poorly controlled asthma |
| Date of disclosure of the study information | 2018/11/18 |
| Last modified on | 2014/11/21 17:52:19 |
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Basic information
Public title
A prospective, randomized, open-label parallel-group clinical study to investigate effects and maneuverability of devices of fluticasone/formoterol pMDI (Flutiform) vs. fluticasone/salmeterol DPI (Adoair Diskus) in patients who have poorly controlled asthma
Acronym
Study on the efficacy of a fixed-dose combination of fluticasone propionate and formoterol fumarate hydrate (Flutiform)
Scientific Title
A prospective, randomized, open-label parallel-group clinical study to investigate effects and maneuverability of devices of fluticasone/formoterol pMDI (Flutiform) vs. fluticasone/salmeterol DPI (Adoair Diskus) in patients who have poorly controlled asthma
Scientific Title:Acronym
Study on the efficacy of a fixed-dose combination of fluticasone propionate and formoterol fumarate hydrate (Flutiform)
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects and device maneuverability of fluticasone/formoterol pMDI (Flutiform) and fluticasone/salmeterol DPI (Adoair Diskus) in patients who have an inadequate response to current long-term management therapies for asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of FEV1 at week 2
Key secondary outcomes
- ACQ
- FEV1%, %FEV1, FEV1
- PEF
- Number of days when therapeutic drugs for asthma attacks are used, number of days when asthma symptoms are present, and asthma symptom score
- Questionnaire scores on inhaler (device maneuverability)
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will be randomly assigned to either Flutiform 50 Aerosol (2 inhalations, 2 times/day) or Adoair Diskus 100 (1 inhalation, 2 times/day) in a 1:1 allocation. The patients assigned to Flutiform 50 Aerosol will be treated with the drug for 2 weeks.
Interventions/Control_2
Patients will be randomly assigned to either Flutiform 50 Aerosol (2 inhalations, 2 times/day) or Adoair Diskus 100 (1 inhalation, 2 times/day) in a 1:1 allocation. The patients assigned to Adoair Diskus 100 will be treated with the drug for 2 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
(1) Outpatients
(2) Patients in Step 2 or higher in treatment described in Asthma Prevention and Management Guideline 2012
(3) Patients with inadequately or poorly controlled asthma with existing therapies (see Asthma Prevention and Management Guideline 2012)
(4) Patients who can use inhalation device properly and have been receiving low doses or more of ICS or ICS/LABA combination drug or taking LABA more than a low dose ICS 4 weeks or longer prior to study registration
(5) Patients who have reversible airflow limitation for 12 months before study initiation (15% or greater improvement of FEV1.0, 15-30 minutes after inhalation of SABA)
(6) Patients who voluntary provide written informed consent form after having been fully informed about and understand the requirements of study participation
Key exclusion criteria
(1) Patients who have experienced adverse drug reactions caused by treatment with an ICS, LABA, or concomitant use or a combination of ICS and LABA
(2) Patients with severe cardiac, hepatic, renal, pulmonary, or hematologic disease
(3) Patients with complications of apparent chronic obstructive pulmonary disease (COPD)
(4) Patients with complications of malignant tumors
(5) Patients with a history of smoking within the past 1 year
(6) Patients who are pregnant, lactating, or desire to conceive during the study period
(7) Patients who were judged unsuitable for enrollment in the study by the investigator or the sub-investigator
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Ikeda |
Organization
Incorporated medical institution, Ikeda-kai, Ikeda internal medicine
Division name
Medical director
Zip code
Address
3-11-2, Ichinomiya-cho, Shimonoseki-shi, Yamaguchi
TEL
083-263-3311
jimukyoku@medical-bs24.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yabe |
Organization
Bell Medical Solutions Inc
Division name
Clinical Research Group, Clinical Research and Development Division
Zip code
Address
Tokyu Bldg. East No. 3, 2-16-8, Minami Ikebukuro, Toshima-ku, Tokyo
TEL
0120-313-626
Homepage URL
jimukyoku@medical-bs24.com
Sponsor or person
Institute
KYORIN Pharmaceutical Co., Ltd.
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
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
医療法人池田会いけだ内科（山口県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 18 | 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
| 2013 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 18 | Day |
Last modified on
| 2014 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014412
