UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Estimating lower airway aerosol inhalant deposition by using Functional Respiratory Imaging (FRI), a novel imaging technology, in asthma patients
Title of the study (Brief title)	Estimating lower airway aerosol inhalant deposition by using Functional Respiratory Imaging (FRI), a novel imaging technology, in asthma patients
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Pneumology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Conduct an explorative investigation of facts about the intrapulmonary deposition of inhalants in Japanese patients with bronchial asthma by creating a model of airway deposition using CT scan technology.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Deposition rate of peripheral airways calculated by FRI-based operation.
Key secondary outcomes	1) The following indexes are calculated by FRI-based operation a. Deposition rate of airways and lobes b. Airway volume and airway resistance 2) Endpoints for respiratory function testing (after inhaling a bronchodilator) FEV1, %FEV1, FEV1%, FVC, Vdot50, Vdot25, %Vdot50, and %Vdot25 3) Endpoints for IOS measurement (after inhaling bronchodilator) R5, R20, R5-R20, X5, AX, Fres, R5 ex-in, R20 ex-in, R5-R20 ex-in, X5 ex-in, AX ex-in and Fres ex-in 4) Correlation between peripheral airway resistance and deposition rate

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	CT
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Diagnosed as bronchial asthma. 2) 20 or older at the time he or she gave consent. 3) Categorized into "mild and persistent" or "moderate and persistent" defined in the 2015 Asthma Prevention and Management Guideline. 4) Good control or better (20 points or more in the asthma control test (ACT)). 5) Written consent in accordance with the patient's free has been given after receiving and sufficiently understanding the explanation about enrollment in this study. 6) No problem in communication. 7) Outpatient
Key exclusion criteria	1) Obviously has a chronic obstructive pulmonary disease (COPD). 2) Has a respiratory tract infection. 3) Determined by the investigator to be ineligible.
Target sample size	6

Research contact person
Name of lead principal investigator	Yuji Tohda
Organization	Kindai University, Faculty of Medicine
Division name	Department of Respiratory Medicine and Allergology
Address	377-2 Ohnohigashi, Osakasayama, Osaka
TEL	072-366-0221
Email	koare-kyoju@med.kindai.ac.jp

Public contact
Name of contact person	Makoto Sawaguchi
Organization	Mebix, Inc.
Division name	Research Promotion Division
Address	Toranomon Towers Office, 4-1-28 Toranomon, Minato-ku, Tokyo
TEL	03-4362-4500
Homepage URL
Email	fri@mebix.co.jp

Sponsor
Institute	Department of Respiratory Medicine and Allergology, Kindai University, Faculty of Medicine
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	近畿大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 06 Day
Anticipated trial start date	2016 Year 06 Month 29 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

Management information
Registered date	2016 Year 06 Month 22 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=R000026105