UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022840
Receipt number R000026105
Scientific Title Estimating lower airway aerosol inhalant deposition by using Functional Respiratory Imaging (FRI), a novel imaging technology, in asthma patients
Date of disclosure of the study information 2016/06/22
Last modified on 2017/06/21 12:42:01

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Basic information

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

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

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


Public contact

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


Sponsor or person

Institute

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

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


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

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


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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026105


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name