UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033822
Receipt No. 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 2018/09/16

* 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
Email 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
Email kmasashi@gm.himeji-du.ac.jp

Sponsor
Institute Himeji Dokkyo University
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 10 Day
Last follow-up date
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
2018 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038571

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.