Clinical trial NCT03626519: Effects of Menthol on Dyspnoea in COPD Patients
Official title: Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Dyspnea
Lung Diseases
Keywords: COPD
Menthol
Exercise
Dyspnea
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Dyspnea after each tests
timeFrame: 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:
measure: Change in respiratory rate
timeFrame: 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.
measure: Change in inspiratory capacity
timeFrame: 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.
measure: Change in Cardiac Frequency
timeFrame: 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.
measure: Change in Oxygen Saturation
timeFrame: 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.
measure: Change in tidal volume
timeFrame: 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.
measure: Change in 6-min walk distance
timeFrame: 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.
Other outcomes:
Locations:
city: Morlaix
country: France
facility: Centre hospitalier des Pays de Morlaix
state: Bretagne
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
state: Normandie
city: Talence
country: France
facility: Resp'Air
state: Nouvelle-Aquitaine
Study officials:
affiliation: Groupe Hospitalier du Havre
name: Guillaume Prieur
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier des Pays de Morlaix
name: Marc Beaumont
role: PRINCIPAL_INVESTIGATOR
affiliation: Resp'Air, Talence
name: Mathieu Delorme
role: PRINCIPAL_INVESTIGATOR
References: