Effects of Menthol on Dyspnoea in COPD Patients

Overview

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.

Full Title of Study: “Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 12, 2021

Interventions

  • Other: Test with Menthol
    • patients will perform a Six-minute walk test according to American Thoracic Society guidelines
  • Other: Test with placebo
    • patients will perform a Six-minute walk test according to American Thoracic Society guidelines

Arms, Groups and Cohorts

  • Experimental: Test with Menthol
    • Patients will chew a menthol flavored chewing gum 5 minutes before perform one Six-minute Walk Test
  • Placebo Comparator: Test with placebo
    • Patients will chew a strawberry flavored chewing gum 5 minutes before perform one Six-minute Walk Test

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Groupe Hospitalier du Havre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Guillaume Prieur, Principal Investigator, Groupe Hospitalier du Havre
    • Marc Beaumont, Principal Investigator, Centre Hospitalier des Pays de Morlaix
    • Mathieu Delorme, Principal Investigator, Resp’Air, Talence

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