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Completed

NCT Number: NCT03626519

Effects of Menthol on Dyspnoea 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.

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Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier des Pays de Morlaix, Morlaix, Brittany Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test with Menthol

Other

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

Test with placebo

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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).

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier du Havre

Other

Registry information

Official study title

Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients

Acronym: MEDiC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2018
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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