Effects of Menthol on Dyspnoea in COPD Patients

Study Overview
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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.

Official Title
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Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients

Conditions
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Copd, Dyspnea, Lung Diseases

Intervention / Treatment
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* Other: Test with Menthol
* Other: Test with placebo


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Menthol, Exercise, Dyspnea