Effects of Menthol on Dyspnoea in COPD Patients (MEDiC)

Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Copd; Dyspnea
• Intervention / Treatment: Other: Test with Menthol; Other: Test with placebo

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Morlaix, Bretagne, France, 29672
      • Centre Hospitalier Des Pays De Morlaix
  • Normandie
    • Le Havre, Normandie, France, 76290
      • Groupe Hospitalier Du Havre
  • Nouvelle-Aquitaine
    • Talence, Nouvelle-Aquitaine, France, 33400
      • Resp'Air

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test with Menthol; Patients will chew a menthol flavored chewing gum 5 minutes before perform one Six-minute Walk Test	Other: Test with Menthol; patients will perform a Six-minute walk test according to American Thoracic Society guidelines
Placebo Comparator: Test with placebo; Patients will chew a strawberry flavored chewing gum 5 minutes before perform one Six-minute Walk Test	Other: Test with placebo; patients will perform a Six-minute walk test according to American Thoracic Society guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dyspnea after each tests	Change in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort	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 Measures

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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier du Havre
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): March 12, 2021
• Study Completion (Actual): March 12, 2021

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; COPD; Dyspnea; Menthol
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Lung Diseases; Dyspnea; Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: 2018-A00585-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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)
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No