CopdMEDiCNCT03626519
Effects of Menthol on Dyspnoea in COPD Patients
A study testing Test with Menthol in people with Copd and Dyspnea, run by Groupe Hospitalier du Havre at 3 sites in France.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Copd, Dyspnea, Lung Diseases
- What is being tested?
- Test with Menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Sep 2019to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a diagnosis of COPD
- Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale)
- Clinically stable
Who cannot join
- exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
- exacerbation during the study
- Inability to chew or patients with swallowing disorders
Trial locations and contacts
3 sites in 1 country.
France3 sites
Groupe Hospitalier du Havre
Le Havre, Normandy, 76290
Centre hospitalier des Pays de Morlaix
Morlaix, Brittany Region, 29672
Resp'Air
Talence, New Aquitaine, 33400
About this study
Official title: Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients
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.
- Conditions
- Copd, Dyspnea, Lung Diseases
- Being tested
- Test with Menthol, Test with placebo
- Keywords
- COPD, Menthol, Exercise, Dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Lung Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test with MentholOther
patients will perform a Six-minute walk test according to American Thoracic Society guidelines
Test with placeboOther
patients will perform a Six-minute walk test according to American Thoracic Society guidelines
| Study group | Role | What they receive |
|---|---|---|
| Test with Menthol | Experimental | Patients will chew a menthol flavored chewing gum 5 minutes before perform one Six-minute Walk Test Receives: Other: Test with Menthol |
| Test with placebo | Placebo comparator | Patients will chew a strawberry flavored chewing gum 5 minutes before perform one Six-minute Walk Test Receives: Other: Test with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dyspnea after each tests
Change in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort
Measured: 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 (6)
Change in respiratory rate
Change in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start23 Sep 2019
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Prieur, Principal investigator, Groupe Hospitalier du HavreMarc Beaumont, Principal investigator, Centre Hospitalier des Pays de MorlaixMathieu Delorme, Principal investigator, Resp'Air, Talence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626519
- Sponsor's protocol ID
- 2018-A00585-50
- Acronym
- MEDiC
- Status last verified
- Apr 2021
- First submitted
- 8 Aug 2018
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data type : deidentified participtant data
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients
- ClinicalTrials.gov ID
- NCT03626519
- Acronym / sponsor ID
- MEDiC / 2018-A00585-50
- Conditions
- Copd, Dyspnea, Lung Diseases
- Keywords
- COPD, Menthol, Exercise, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test with Menthol | Experimental | Other: Test with MentholPatients will chew a menthol flavored chewing gum 5 minutes before perform one Six-minute Walk Test |
| Test with placebo | Placebo comparator | Other: Test with placeboPatients will chew a strawberry flavored chewing gum 5 minutes before perform one Six-minute Walk Test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a diagnosis of COPD
- Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale)
- Clinically stable
Key exclusion criteria (3 listed)
- exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
- exacerbation during the study
- Inability to chew or patients with swallowing disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test with Mentholpatients will perform a Six-minute walk test according to American Thoracic Society guidelines | Other | Test with Menthol |
| Test with placebopatients will perform a Six-minute walk test according to American Thoracic Society guidelines | Other | Test with placebo |
Primary outcome
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
6 secondary outcomes
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 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 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 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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: Yes. Data type : deidentified participtant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Prieur principal investigator
Groupe Hospitalier du Havre
Marc Beaumont principal investigator
Centre Hospitalier des Pays de Morlaix
Mathieu Delorme principal investigator
Resp'Air, Talence
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test with Menthol in people with Copd and Dyspnea, run by Groupe Hospitalier du Havre at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.