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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03626519
Other study ID # 2018-A00585-50
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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