UMIN-CTR Clinical Trial

Public title

Estimating lower airway aerosol inhalant deposition by using Functional Respiratory Imaging (FRI), a novel imaging technology, in asthma patients

Acronym

Estimating lower airway aerosol inhalant deposition by using Functional Respiratory Imaging (FRI), a novel imaging technology, in asthma patients

Scientific Title

Estimating lower airway aerosol inhalant deposition by using Functional Respiratory Imaging (FRI), a novel imaging technology, in asthma patients

Scientific Title:Acronym

Estimating lower airway aerosol inhalant deposition by using Functional Respiratory Imaging (FRI), a novel imaging technology, in asthma patients

Region

Japan

Condition

Bronchial asthma

Classification by specialty

Pneumology

Radiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yuji Tohda

Organization

Kindai University, Faculty of Medicine

Division name

Department of Respiratory Medicine and Allergology

Zip code

Address

377-2 Ohnohigashi, Osakasayama, Osaka

TEL

072-366-0221

Email

koare-kyoju@med.kindai.ac.jp

Name of contact person

1st name
Middle name
Last name	Makoto Sawaguchi

Organization

Mebix, Inc.

Division name

Research Promotion Division

Zip code

Address

Toranomon Towers Office, 4-1-28 Toranomon, Minato-ku, Tokyo

TEL

03-4362-4500

Homepage URL

Email

fri@mebix.co.jp

Institute

Department of Respiratory Medicine and Allergology, Kindai University, Faculty of Medicine

Institute

Department

Personal name

Organization

Kyorin Pharmaceutical Co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

近畿大学医学部附属病院（大阪府）

Date of disclosure of the study information

2016

Year

06

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

06

Month

06

Day

Date of IRB

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

Other related information

Registered date

2016

Year

06

Month

22

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=R000026105