UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018449 |
|---|---|
| Receipt number | R000021361 |
| Scientific Title | Study on switching from combined therapy with fluticasone and salmeterol (Adair Discus) to that with fluticasone and formoterol (Flutiform) in elderly patients with asthma |
| Date of disclosure of the study information | 2015/07/28 |
| Last modified on | 2016/02/24 11:57:11 |
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Basic information
Public title
Study on switching from combined therapy with fluticasone and salmeterol (Adair Discus) to that with fluticasone and formoterol (Flutiform) in elderly patients with asthma
Acronym
Study on switching from combined therapy with fluticasone and salmeterol (Adair Discus) to that with fluticasone and formoterol (Flutiform) in elderly patients with asthma
Scientific Title
Study on switching from combined therapy with fluticasone and salmeterol (Adair Discus) to that with fluticasone and formoterol (Flutiform) in elderly patients with asthma
Scientific Title:Acronym
Study on switching from combined therapy with fluticasone and salmeterol (Adair Discus) to that with fluticasone and formoterol (Flutiform) in elderly patients with asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Switching from combined therapy with fluticasone and salmeterol (Adair Discus) to that with fluticasone and formoterol (Flutiform) in elderly patients with asthma will be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FEV1
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Observation period: combined therapy with fluticasone and salmeterol (Adair Discus) for 2-4 weeks
Treatment period: combined therapy with fluticasone and formoterol (Flutiform) for 8 weeks
Interventions/Control_2
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Observation period>
Those who fulfill the following criteria at Visit 1 are eligible:
1) Outpatients aged 60 years or more at informed consent
2) Patients with asthma that is insufficiently or poorly controlled according to JGL2012
3) Patients with asthma that can be treated according to its severity
4) Those who have been treated with a constant dose of Adair Discus for at least 4 weeks
5) Those who can provide informed consent in writing
<Treatment period>
Those who fulfill the following criteria at Visit 2 are eligible:
1) Those who did not develop respiratory tract infection or upper respiratory tract inflammation during the observation period
2) Those in whom asthma was not aggravated by urgent treatment or drugs for long-term control during the observation period. For aggravated asthma, systemic steroids, aminophylline infusion, and on-demand SABA can be used.
3) Those in whom the severity of asthma according to JGL2012 remains the same as at Visit 1.
4) Those in whom asthma was treated with a constant dose of Adair Discus during the observation period.
5) Those who the investigator or sub-investigator judges are eligible
Key exclusion criteria
Those who meet any of the following criteria below at Visit 1 are ineligible:
1) Previous diseases/complications:
- Those in whom respiratory tract infection or upper respiratory tract inflammation is seen.
Those who the investigator judges are eligible are to be included even if any of the following complications is seen: infections other than respiratory tract infection, hyperthyroidism, hypertension, heart diseases, diabetes, and hypercalcemia.
- Those who the investigator judges are ineligible due to serious heart/liver/kidney/lung/blood diseases or other serious complications
- Those who have or have had malignant tumors in the past 5 years
- Those who have antibiotic-resistant infections or deep mycosis
- Those who had an aggravation of asthma requiring hospitalization, urgent treatment, or changes in drugs for long-term control within 4 weeks of enrollment
2) Medications/therapies
- Those who developed moderate or worse adverse drug reactions requiring medications or other treatments when treated with ICS or/and LABA
- Those who are taking SABA regularly or for preventive purposes, including those who are taking drugs for asthma attack improperly (using unapproved dosage/administration)
3) Others
- Those who cannot properly use inhalants
- Those who cannot properly undergo a respiratory function test
- Those who the investigator or sub-investigator judges are ineligible
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nagase |
Organization
Teikyo University Hospital
Division name
Department of Respiratory Medicine/Allergy
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
+81-3-3964-8351
nagaseh@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhide Mori |
Organization
Mebix, Inc.
Division name
Research Promotion Head 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
Teikyo 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
帝京大学医学部附属病院（東京）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 28 | 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 | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 12 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 28 | Day |
Last modified on
| 2016 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021361
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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