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

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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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name