Effects of Menthol on Dyspnoea in COPD Patients (MEDiC)

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ClinicalTrials.gov Identifier: NCT03626519

Recruitment Status : Completed

First Posted : August 13, 2018

Last Update Posted : April 23, 2021

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Groupe Hospitalier du Havre

Tracking Information

First Submitted Date ^ICMJE

August 8, 2018

First Posted Date ^ICMJE

August 13, 2018

Last Update Posted Date

April 23, 2021

Actual Study Start Date ^ICMJE

September 23, 2019

Actual Primary Completion Date

March 12, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Dyspnea after each tests [ Time Frame: The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]

Change in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort

Original Primary Outcome Measures ^ICMJE

Difference in Dyspnea after each tests [ Time Frame: The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]

Difference in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort

Change History

Current Secondary Outcome Measures ^ICMJE

Change in respiratory rate [ Time Frame: Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Change in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography
Change in inspiratory capacity [ Time Frame: The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Change in inspiratory capacity (Liters) will be measured using a portable spirometer
Change in Cardiac Frequency [ Time Frame: Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Change in Cardiac Frequence (bpm) using a pulse oximetry
Change in Oxygen Saturation [ Time Frame: Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Change in Oxygen Saturation (%) using a pulse oximetry
Change in tidal volume [ Time Frame: The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Change in tidal volume (Liters) will be measured breath-by-breath using a portable spirometer
Change in 6-min walk distance [ Time Frame: The outcome will be measured at the end of each tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Change in 6-min walk distance (meters).

Original Secondary Outcome Measures ^ICMJE

Difference in respiratory rate [ Time Frame: Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Difference in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography
Difference in inspiratory capacity [ Time Frame: The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Difference in inspiratory capacity (Liters) will be measured using a portable spirometer
Difference in Cardiac Frequency [ Time Frame: Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Difference in Cardiac Frequence (bpm) using a pulse oximetry
Difference in Oxygen Saturation [ Time Frame: Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Difference in Oxygen Saturation (%) using a pulse oximetry
Difference in tidal volume [ Time Frame: The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Difference in tidal volume (Liters) will be measured breath-by-breath using a portable spirometer
Difference in 6-min walk distance [ Time Frame: The outcome will be measured at the end of each tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. ]
Difference in 6-min walk distance (meters).

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Menthol on Dyspnoea in COPD Patients

Official Title ^ICMJE

Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients

Brief Summary

Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. Dyspnoea is a common symptom among patients with Chronic Obstructive pulmonary Disease (COPD). Dyspnea is the primary symptom limiting exercise and daily activities in these patients. It has been reported that breathing cold air could decrease dyspnoea induced by exercise and could improve exercise performance. The aim of this study is to carry out the effect of cooling sensation induced by menthol chewing-gum on dyspnoea and exercise performance among patients with COPD.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other

Condition ^ICMJE

Copd
Dyspnea
Lung Diseases

Intervention ^ICMJE

Other: Test with Menthol
patients will perform a Six-minute walk test according to American Thoracic Society guidelines
Other: Test with placebo
patients will perform a Six-minute walk test according to American Thoracic Society guidelines

Study Arms ^ICMJE

Experimental: Test with Menthol
Patients will chew a menthol flavored chewing gum 5 minutes before perform one Six-minute Walk Test

Intervention: Other: Test with Menthol
Placebo Comparator: Test with placebo
Patients will chew a strawberry flavored chewing gum 5 minutes before perform one Six-minute Walk Test

Intervention: Other: Test with placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

March 12, 2021

Actual Primary Completion Date

March 12, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

a diagnosis of COPD
Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale)
Clinically stable

Exclusion Criteria:

exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
exacerbation during the study
Inability to chew or patients with swallowing disorders

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

Child, Adult, Older Adult

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03626519

Other Study ID Numbers ^ICMJE

2018-A00585-50

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	Data type : deidentified participtant data
Supporting Materials:	Clinical Study Report (CSR)
Time Frame:	after publication
Access Criteria:	the request shall be sent to Guillaume Prieur (gprieur.kine@gmail.com)

Current Responsible Party

Groupe Hospitalier du Havre

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Groupe Hospitalier du Havre

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Guillaume Prieur	Groupe Hospitalier du Havre
Principal Investigator:	Marc Beaumont	Centre Hospitalier des Pays de Morlaix
Principal Investigator:	Mathieu Delorme	Resp'Air, Talence

PRS Account

Groupe Hospitalier du Havre

Verification Date

April 2021

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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