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
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
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
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
