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Effects of Menthol on Dyspnoea in COPD Patients (MEDiC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626519
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier du Havre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Copd Dyspnea Lung Diseases Other: Test with Menthol Other: Test with placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients
Actual Study Start Date : September 23, 2019
Actual Primary Completion Date : March 12, 2021
Actual Study Completion Date : March 12, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Test with Menthol
Patients will chew a menthol flavored chewing gum 5 minutes before perform one Six-minute Walk Test
 Other: Test with Menthol
patients will perform a Six-minute walk test according to American Thoracic Society guidelines
Placebo Comparator: Test with placebo
Patients will chew a strawberry flavored chewing gum 5 minutes before perform one Six-minute Walk Test
 Other: Test with placebo
patients will perform a Six-minute walk test according to American Thoracic Society guidelines


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626519


Locations
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France
Centre hospitalier des Pays de Morlaix
Morlaix, Bretagne, France, 29672
Groupe Hospitalier du Havre
Le Havre, Normandie, France, 76290
Resp'Air
Talence, Nouvelle-Aquitaine, France, 33400
Sponsors and Collaborators
Groupe Hospitalier du Havre
Investigators
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Principal Investigator: Guillaume Prieur Groupe Hospitalier du Havre
Principal Investigator: Marc Beaumont Centre Hospitalier des Pays de Morlaix
Principal Investigator: Mathieu Delorme Resp'Air, Talence
More Information
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Responsible Party: Groupe Hospitalier du Havre
ClinicalTrials.gov Identifier: NCT03626519    
Other Study ID Numbers: 2018-A00585-50
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data type : deidentified participtant data
Supporting Materials: Clinical Study Report (CSR)
Time Frame: after publication
Access Criteria: the request shall be sent to Guillaume Prieur (gprieur.kine@gmail.com)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier du Havre:
COPD
Menthol
Exercise
Dyspnea
Additional relevant MeSH terms:
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Lung Diseases
Dyspnea
Respiratory Tract Diseases
Respiration Disorders
 Signs and Symptoms, Respiratory
Menthol
Antipruritics
Dermatologic Agents