UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Translational research of devices for simulation experience of chronic obstructive pulmonary disease in healthy subjects
Title of the study (Brief title)	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	Tomotaka Kawayama
Organization	Kurume University School of Medicine
Division name	Medicine
Address	67 Asahimachi, Kurume
TEL	0942-31-7560
Email	kawayama_tomotaka@med.kurume-u.ac.jp

Public contact
Name of contact person	Tomotaka Kawayama
Organization	Kurume University
Division name	Medicine
Address	67 Asahimachi, Kurume
TEL	0942-31-7560
Homepage URL
Email	kawayama_tomotaka@med.kurume-u.ac.jp

Sponsor
Institute	Kurume Univeristy
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017035