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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014644
Receipt No. 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

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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
Last 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
1st 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
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)

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
URL(English) https://upload.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


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