UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of medication use guidance on the level of control in patients with partly controlled or uncontrolled asthma despite ICS/LABA treatment
Title of the study (Brief title)	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	Yuji Tohda
Organization	Faculty of Medicine, Kindai University
Division name	Department of Respiratory Medicine and Allergology
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	Naoyoshi Sugiyama
Organization	Mebix, Inc.
Division name	Research promotion division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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