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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024353
Receipt No. 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

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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
Email 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
Email flutiform@mebix.co.jp

Sponsor
Institute Kindai University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028038

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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