Effects of Menthol on Dyspnoea in COPD Patients

NCT03626519 | Completed

• 1 other identifier: 2018-A00585-50
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Copd; Dyspnea; Lung Diseases

Keywords

COPD; Menthol; Exercise; Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in respiratory rate

  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

  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

  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

  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

  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.

Study Arms (2)

Test with Menthol

EXPERIMENTAL

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

Other: Test with Menthol

Test with placebo

PLACEBO COMPARATOR

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

Other: Test with placebo

Interventions

Test with Menthol OTHER

patients will perform a Six-minute walk test according to American Thoracic Society guidelines

Test with Menthol

Test with placebo OTHER

patients will perform a Six-minute walk test according to American Thoracic Society guidelines

Test with placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (3)

Centre hospitalier des Pays de Morlaix

Morlaix, Brittany Region, 29672, France

Location

Groupe Hospitalier du Havre

Le Havre, Normandy, 76290, France

Location

Resp'Air

Talence, Nouvelle-Aquitaine, 33400, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Lung Diseases; Motor Activity

Interventions

Menthol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Study Officials

• Guillaume Prieur

  Groupe Hospitalier du Havre

  PRINCIPAL INVESTIGATOR

• Marc Beaumont

  Centre Hospitalier des Pays de Morlaix

  PRINCIPAL INVESTIGATOR

• Mathieu Delorme

  Resp'Air, Talence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: September 23, 2019
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: after publication
• Access Criteria: the request shall be sent to Guillaume Prieur (gprieur.kine@gmail.com)

Locations

FR (3)