Effects of Menthol on Dyspnoea in COPD Patients

Copd Clinical Trial

— MEDiC  

Official title:

Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626519
• Other study ID #: 2018-A00585-50
• Status: Completed
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: March 12, 2021

Study information

• Verified date: April 2021
• Source: Groupe Hospitalier du Havre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Copd
• Dyspnea
• Lung Diseases

Intervention

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

Locations

Country	Name	City	State
France	Groupe Hospitalier du Havre	Le Havre	Normandie
France	Centre hospitalier des Pays de Morlaix	Morlaix	Bretagne
France	Resp'Air	Talence	Nouvelle-Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.