UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014644
Receipt number R000017035
Scientific Title Translational research of devices for simulation experience of chronic obstructive pulmonary disease in healthy subjects
Date of disclosure of the study information 2014/08/01
Last modified on 2017/10/03 18:17:30

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Basic information

Public title

Translational research of devices for simulation experience of chronic obstructive pulmonary disease in healthy subjects

Acronym

Translational research of devices for COPD simulation experience

Scientific Title

Translational research of devices for simulation experience of chronic obstructive pulmonary disease in healthy subjects

Scientific Title:Acronym

Translational research of devices for COPD simulation experience

Region

Japan


Condition

Condition

healthy subjects

Classification by specialty

Pneumology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will evaluate the efficacy and safety of devices, such as the perception of dyspnea, intraoral pressure, pulmonary function, respiratory resistance, and adverse events in healthy adult subjects when each device will be used. We will also investigate whether the device will be useful to improve the motivation to tobacco cessation in healthy smokers.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation the efficacy and safety of devices for COPD simulation experience in healthy subjects

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Grade 1 COPD simulation experience, 7min/day, 1day in each

Interventions/Control_2

Grade 2 COPD simulation experience, 7min/day, 1day in each

Interventions/Control_3

Grade 3 COPD simulation experience, 7min/day, 1day in each

Interventions/Control_4

Grade 4 COPD simulation experience, 7min/day, 1day in each

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

50 years-old >=

Gender

Male and Female

Key inclusion criteria

Thirty-two healthy adults (Eight nonsmoker males, 8 nonsmoker females, 8 current smoker males, and 8 current smoker females)

1. good healthy status
2. Aged 20 to 50 yrs
3. Applicable spirometry

Key exclusion criteria

1 respiratory rates >20/min at rest and room air
2 systolic blood pressure > 150mmHg at rest
3 heart beat >90beats/min at rest
4 saturation of oxygen <94% with pulse oximetory at rest and room air
5 %vital capacity predicted <80%, %forced expiratory volume in 1 second predicted >80%, and/or FEV1/forced vital capacity <70% by spirometry
6 history and present of severe diseases of any organs
7 history of lung surgery
8 respiratory tract infections within 4 weeks prior to a day of examinations
9 during pregnancy or nursing

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomotaka Kawayama

Organization

Kurume University School of Medicine

Division name

Medicine

Zip code


Address

67 Asahimachi, Kurume

TEL

0942-31-7560

Email

kawayama_tomotaka@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomotaka Kawayama

Organization

Kurume University

Division name

Medicine

Zip code


Address

67 Asahimachi, Kurume

TEL

0942-31-7560

Homepage URL


Email

kawayama_tomotaka@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume Univeristy

Institute

Department

Personal name



Funding Source

Organization

Kurume Univeristy

Organization

Division

Category of Funding Organization

Other

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

2014 Year 08 Month 01 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

2014 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 01 Day

Last follow-up date

2016 Year 07 Month 31 Day

Date of closure to data entry

2016 Year 07 Month 31 Day

Date trial data considered complete

2016 Year 07 Month 31 Day

Date analysis concluded

2016 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 07 Month 25 Day

Last modified on

2017 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017035


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name