Effects of Menthol on Dyspnoea in COPD Patients

NCT ID: NCT03626519

Last Updated: 2021-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-23

Study Completion Date

2021-03-12

Brief Summary

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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

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Conditions

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Copd Dyspnea Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Test with Menthol

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

Group Type EXPERIMENTAL

Test with Menthol

Intervention Type OTHER

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

Test with placebo

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

Group Type PLACEBO_COMPARATOR

Test with placebo

Intervention Type OTHER

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

Interventions

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Test with Menthol

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

Intervention Type OTHER

Test with placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier du Havre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Prieur

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier du Havre

Marc Beaumont

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier des Pays de Morlaix

Mathieu Delorme

Role: PRINCIPAL_INVESTIGATOR

Resp'Air, Talence

Locations

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Centre hospitalier des Pays de Morlaix

Morlaix, Brittany Region, France

Site Status

Groupe Hospitalier du Havre

Le Havre, Normandy, France

Site Status

Resp'Air

Talence, Nouvelle-Aquitaine, France

Site Status

Countries

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France

Other Identifiers

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2018-A00585-50

Identifier Type: -

Identifier Source: org_study_id

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