UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024353 |
|---|---|
| Receipt number | R000028038 |
| Scientific Title | Effect of medication use guidance on the level of control in patients with partly controlled or uncontrolled asthma despite ICS/LABA treatment |
| Date of disclosure of the study information | 2016/10/11 |
| Last modified on | 2017/06/21 12:39:39 |
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Basic information
Public title
Effect of medication use guidance on the level of control in patients with partly controlled or uncontrolled asthma despite ICS/LABA treatment
Acronym
Effect of medication use guidance on the level of control in patients with partly controlled or uncontrolled asthma despite ICS/LABA treatment
Scientific Title
Effect of medication use guidance on the level of control in patients with partly controlled or uncontrolled asthma despite ICS/LABA treatment
Scientific Title:Acronym
Effect of medication use guidance on the level of control in patients with partly controlled or uncontrolled asthma despite ICS/LABA treatment
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of medication use guidance on the level of control in patients with partly controlled or uncontrolled asthma on ICS/LABA treatment, using the newly developed JACS (Japan Asthma Control Survey) questionnaire for assessment of asthma control level as an additional evaluation index
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in JACS score (total score) between week 0 (Visit 1) and week 4 (Visit 2)
Key secondary outcomes
(1) Control level
(2) QOL assessment (MiniAQLQ)
(3) Respiratory function tests
(4) JACS questionnaire accuracy
(5) Confirmation of inhalation technique
(6) ICS/LABA drug-specific evaluation (including device-specific evaluation) of the above items
(7) Analysis of the above items according to patient demographic factors
(8) JACS cut-off value calculation
(9) Correlation(s) between JACS, ACQ and MiniAQLQ
(10) Correlation(s) of items within the JACS questionnaire
(11) Consideration of the clinical significance of the JACS questionnaire
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria at the visit1:
(1) Asthma patients (patients diagnosed with mild to severe persistent type according to JGL 2015, accounting for current treatment in the severity classification)
(2) Patients who can provide written consent
(3) Patients between 20 and 80 years old
(4) Patients who have been using ICS/LABA for at least 4 weeks
(5) Patients with partly controlled(fulfill at least 2 criteria for inadequate control) or uncontrolled asthma according to JGL 2015
(6) Patients planned for medication use guidance
(7) Patients with the ability to adequately understand the method of inhaler use, as well as adequately maintained motor function of the fingers for the purpose of inhaler use
(8) Patients without communication problems
Key exclusion criteria
Patients who meet any of the following criteria at the visit1 are not selected as subjects:
(1) Patients with a clear concomitant diagnosis of COPD
(2) Patients with a concomitant diagnosis of malignant tumor
(3) Patients with a history of smoking within the past 1 year
(4) Patients with a history of respiratory infection (including viral infection) within the past 4 weeks
(5) Patients who have experienced side effects from the use of ICS, LABA or the combined medications
(6) Patients with a contraindication to the use of ICS and/or LABA
(7) Patients who are using long-term oral steroids or are using anti-IgE antibodies
(8) Patients who have deformation or palsy of the fingers, such that it is determined that they cannot correctly use the inhaler
(9) Patients with dementia, etc., for which it has been determined that they cannot adequately understand the method of inhaler use
(10) Patients who are pregnant, breastfeeding, or hoping to become pregnant during the study period
(11) Other patients who are judged by the researchers to be unsuitable as a subject
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Tohda |
Organization
Faculty of Medicine, Kindai University
Division name
Department of Respiratory Medicine and Allergology
Zip code
Address
377-2 Onohigashi, Osakasayama, Osaka 589-8511
TEL
072-366-0221
koare-kyoju@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyoshi Sugiyama |
Organization
Mebix, Inc.
Division name
Research promotion division
Zip code
Address
Toranomon Towers Office, 4-1-28 Toranomon, Minato-ku, Tokyo, 105-0001
TEL
03-4362-4504
Homepage URL
flutiform@mebix.co.jp
Sponsor or person
Institute
Kindai University
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
| 2016 | Year | 10 | Month | 11 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective multicenter observational study
Registration period: October 1st 2016 to February 28th 2017
Study duration: October 1st 2016 to March 31st 2017
Study duration: 4 weeks
Management information
Registered date
| 2016 | Year | 10 | Month | 11 | Day |
Last modified on
| 2017 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028038
