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Effects of Menthol on Dyspnoea in COPD Patients (MEDiC)

Primary Purpose

Copd, Dyspnea, Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Test with Menthol
Test with placebo
Sponsored by
Groupe Hospitalier du Havre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Copd focused on measuring COPD, Menthol, Exercise, Dyspnea

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre hospitalier des Pays de Morlaix
  • Groupe Hospitalier du Havre
  • Resp'Air

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test with Menthol

Test with placebo

Arm Description

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

Patients will chew a strawberry flavored chewing gum 5 minutes before perform one Six-minute Walk Test

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in respiratory rate
Change in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography
Change in inspiratory capacity
Change in inspiratory capacity (Liters) will be measured using a portable spirometer
Change in Cardiac Frequency
Change in Cardiac Frequence (bpm) using a pulse oximetry
Change in Oxygen Saturation
Change in Oxygen Saturation (%) using a pulse oximetry
Change in tidal volume
Change in tidal volume (Liters) will be measured breath-by-breath using a portable spirometer
Change in 6-min walk distance
Change in 6-min walk distance (meters).

Full Information

First Posted
August 8, 2018
Last Updated
April 22, 2021
Sponsor
Groupe Hospitalier du Havre
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1. Study Identification

Unique Protocol Identification Number
NCT03626519
Brief Title
Effects of Menthol on Dyspnoea in COPD Patients
Acronym
MEDiC
Official Title
Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier du Havre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Dyspnea, Lung Diseases
Keywords
COPD, Menthol, Exercise, Dyspnea

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test with Menthol
Arm Type
Experimental
Arm Description
Patients will chew a menthol flavored chewing gum 5 minutes before perform one Six-minute Walk Test
Arm Title
Test with placebo
Arm Type
Placebo Comparator
Arm Description
Patients will chew a strawberry flavored chewing gum 5 minutes before perform one Six-minute Walk Test
Intervention Type
Other
Intervention Name(s)
Test with Menthol
Intervention Description
patients will perform a Six-minute walk test according to American Thoracic Society guidelines
Intervention Type
Other
Intervention Name(s)
Test with placebo
Intervention Description
patients will perform a Six-minute walk test according to American Thoracic Society guidelines
Primary Outcome Measure Information:
Title
Change in Dyspnea after each tests
Description
Change in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort
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.
Secondary Outcome Measure Information:
Title
Change in respiratory rate
Description
Change in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography
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.
Title
Change in inspiratory capacity
Description
Change in inspiratory capacity (Liters) will be measured using a portable spirometer
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.
Title
Change in Cardiac Frequency
Description
Change in Cardiac Frequence (bpm) using a pulse oximetry
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.
Title
Change in Oxygen Saturation
Description
Change in Oxygen Saturation (%) using a pulse oximetry
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.
Title
Change in tidal volume
Description
Change in tidal volume (Liters) will be measured breath-by-breath using a portable spirometer
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.
Title
Change in 6-min walk distance
Description
Change in 6-min walk distance (meters).
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Prieur
Organizational Affiliation
Groupe Hospitalier du Havre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Beaumont
Organizational Affiliation
Centre Hospitalier des Pays de Morlaix
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mathieu Delorme
Organizational Affiliation
Resp'Air, Talence
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier des Pays de Morlaix
City
Morlaix
State/Province
Bretagne
ZIP/Postal Code
29672
Country
France
Facility Name
Groupe Hospitalier du Havre
City
Le Havre
State/Province
Normandie
ZIP/Postal Code
76290
Country
France
Facility Name
Resp'Air
City
Talence
State/Province
Nouvelle-Aquitaine
ZIP/Postal Code
33400
Country
France

12. IPD Sharing Statement

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

Learn more about this trial

Effects of Menthol on Dyspnoea in COPD Patients

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