UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033822 |
|---|---|
| Receipt number | R000038571 |
| Scientific Title | Effect of cooling sensation induced by olfactory stimulation by L-menthol on dyspnea during inspiratory resistive load breathing in healthy, elderly and COPD people. |
| Date of disclosure of the study information | 2018/09/02 |
| Last modified on | 2020/08/20 09:44:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of cooling sensation induced by olfactory stimulation by L-menthol on dyspnea during inspiratory resistive load breathing in healthy, elderly and COPD people.
Acronym
Effect of Menthol on Dyspnea in COPD (MeDCOPD STUDY)
Scientific Title
Effect of cooling sensation induced by olfactory stimulation by L-menthol on dyspnea during inspiratory resistive load breathing in healthy, elderly and COPD people.
Scientific Title:Acronym
Effect of Menthol on Dyspnea in COPD (MeDCOPD STUDY)
Region
| Japan |
Condition
Condition
Healthy, elderly and COPD people.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to investigate
the effect of cognitive illusion of airway flow evoked by cooling sensation by olfactory stimulation by l-menthol on dyspnea during inspiratory resistive load breathing in healthy, elderly and COPD people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dyspnea by modified Borg scale. Japanese version of multidimensional dyspnea profile,
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
olfactory stimulation by l-menthol
Interventions/Control_2
placebo
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy college students, elderly people (from 60 to 85 years old) without exclusion criteria and stable COPD patients (from 60 to 85 years old) at Terada internal medicine and respiration .
Key exclusion criteria
The history of cardiopulmonary diseases, rhinitis, seasonal allergy, sinusitis, myocardial infarction, pneumothorax, exacerbations within 8 weeks and common cold within 4 weeks.
If participants feels coughing or uncomfortable with perfume or smell.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Kanezaki |
Organization
Himeji Dokkyo University
Division name
Department of Physical Therapy, Faculty of Health Care Sciences.
Zip code
Address
7-2-1, Kamiono, Himeji, Hyogo, Japan
TEL
0782236732
kmasashi@gm.himeji-du.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Kanezaki |
Organization
Himeji Dokkyo University
Division name
Department of Physical Therapy, Faculty of Health Care Sciences.
Zip code
Address
7-2-1, Kamiono, Himeji, Hyogo, Japan
TEL
0782236732
Homepage URL
kmasashi@gm.himeji-du.ac.jp
Sponsor or person
Institute
Himeji Dokkyo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Terada internal medicine and respiration
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
| 2018 | Year | 09 | Month | 02 | 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
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 20 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038571
