Chronic Obstructive Pulmonary Disease (COPD)Phase 2Ment-COPDNCT05888597
Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease
A Phase 2 study testing L-menthol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- L-menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 24 May 2023to 30 Apr 2025
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has given written consent to participate in the study
- Diagnosis of COPD confirmed by spirometry and a FEV1 < 80% of predicted post bronchodilator at baseline
- age 18 years or older
- able to cycle
- able to understand and talk Swedish to participate in the study procedures, as judged by the Investigator.
Who cannot join
- Resting peripheral oxygen saturation (SpO2) < 92%
- hospitalization or clinical instability during the last four weeks
- treatment with supplementary oxygen at rest or during exercise
- contraindication to exercise testing in accordance with clinical practice guidelines
- expected survival shorter than six months as judged by the Investigator
- medical conditions including congestive heart failure, acute coronary artery disease, neuromuscular diseases, severe psychiatric illness, and olfaction disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of L-menthol on Breathlessness and Exercise Capacity in Chronic Obstructive Pulmonary Disease: a Randomized
The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD).
Read the detailed description
Breathelssness (Dyspnea) is a cardinal symptom in patients with chronic obstructive pulmonary disease (COPD), often triggered by daily-life physical activities. Despite optimal treatment of the underlying disease, many patients still suffer from chronic and disabling dyspnea for many years, leading to exercise intolerance, and worse morbidity and mortality. To date, an effective pharmacologic treatment to relieve chronic dyspnea is lacking. Recent pilot data support that inhaled L-menthol can markedly decrease laboratory-induced dyspnea in COPD patients, likely through increased afferent feedback of airflow in the airways by inducing a cooling sensation through olfactory stimulation. The aim of this study is therefore to assess the effectiveness and mechanisms of inhaled menthol for relief of chronic dyspnea in patients with COPD.
- Being tested
- L-menthol, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-mentholDrug
(Sigma-Aldrich, St. Louis, US)
PlaceboOther
Strawberry scent (Sigma-Aldrich, St. Louis, US)
| Study group | Role | What they receive |
|---|---|---|
| Menthol | Experimental | In the trial, 30 minutes prior to performing submaximal CPET, participants will be administered, L-menthol patch which will be attached to the inside of a facemask that is connected to the breathing circuit. Receives: Drug: L-menthol |
| Placebo | Placebo comparator | For placebo, the patch will contain a similarly patch with strawberry scent. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness intensity
The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.
Measured: Through study completion, up to 1 year
Secondary outcomes (18)
Dyspnea unpleasantness
The difference between treatment conditions in dyspnea unpleasantness (Borg CR10 scale) at iso-time.
Measured: Through study completion, up to 1 year
Total time
Time to the limit of tolerance (s) (tLIM)
Measured: Through study completion, up to 1 year
Exercise capacity
V'O2 (aerobic exercise capacity, absolute and in %pred)
Measured: Through study completion, up to 1 year
Work load
Workload (W and %pred)
Measured: Through study completion, up to 1 year
Minute ventilation
Minute ventilation
Measured: Through study completion, up to 1 year
Tidal volume (VT)
Tidal volume (VT)
Measured: Through study completion, up to 1 year
Ventilatory reserve
Ventilatory reserve, defined as maximal voluntary ventilation (MVV) - VE
Measured: Through study completion, up to 1 year
Cardiac reserve
Cardiac reserve, evaluated using the predicted peak heart rate
Measured: Through study completion, up to 1 year
Inspiratory capacity
Inspiratory capacity (IC) during exercise
Measured: Through study completion, up to 1 year
Breathing frequency
Breathing frequency during exercise
Measured: Through study completion, up to 1 year
Peak dyspnea intensity
Dyspnea intensity at peak exercise (Borg CR10)
Measured: Through study completion, up to 1 year
Leg discomfort
Leg discomfort (Borg CR10)
Measured: Through study completion, up to 1 year
Anaerobic threshold
Timing (and V'O2) of the anaerobic threshold (AT)
Measured: Through study completion, up to 1 year
Ventilatory efficacy
Efficacy of ventilation (VE/V'CO2-slope)
Measured: Through study completion, up to 1 year
Respiratory exchange ratio
Respiratory exchange ratio (RER), defined as V'CO2/V'O2
Measured: Through study completion, up to 1 year
Saturation
O2-saturation
Measured: Through study completion, up to 1 year
Stop reason
Causes of stopping the test
Measured: Through study completion, up to 1 year
Adverse events
Any adverse events during the test
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start24 May 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multi-center, randomized (ratio 1:1), double-blinded, placebo-controlled, crossover trial (RCT) design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Zainab Ahmadi, MD, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888597
- Sponsor's protocol ID
- Ment-COPD
- Acronym
- Ment-COPD
- Status last verified
- Nov 2025
- First submitted
- 2 May 2023
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of L-menthol on Breathlessness and Exercise Capacity in Chronic Obstructive Pulmonary Disease: a Randomized
- ClinicalTrials.gov ID
- NCT05888597
- Acronym / sponsor ID
- Ment-COPD / Ment-COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 24 May 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Jun 2023 (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.
The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD).
Detailed description
Breathelssness (Dyspnea) is a cardinal symptom in patients with chronic obstructive pulmonary disease (COPD), often triggered by daily-life physical activities. Despite optimal treatment of the underlying disease, many patients still suffer from chronic and disabling dyspnea for many years, leading to exercise intolerance, and worse morbidity and mortality. To date, an effective pharmacologic treatment to relieve chronic dyspnea is lacking. Recent pilot data support that inhaled L-menthol can markedly decrease laboratory-induced dyspnea in COPD patients, likely through increased afferent feedback of airflow in the airways by inducing a cooling sensation through olfactory stimulation. The aim of this study is therefore to assess the effectiveness and mechanisms of inhaled menthol for relief of chronic dyspnea in patients with COPD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Multi-center, randomized (ratio 1:1), double-blinded, placebo-controlled, crossover trial (RCT) design
| Arm | Type | Receives |
|---|---|---|
| Menthol | Experimental | Drug: L-mentholIn the trial, 30 minutes prior to performing submaximal CPET, participants will be administered, L-menthol patch which will be attached to the inside of a facemask that is connected to the breathing circuit. |
| Placebo | Placebo comparator | Other: PlaceboFor placebo, the patch will contain a similarly patch with strawberry scent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject has given written consent to participate in the study
- Diagnosis of COPD confirmed by spirometry and a FEV1 < 80% of predicted post bronchodilator at baseline
- age 18 years or older
- able to cycle
- able to understand and talk Swedish to participate in the study procedures, as judged by the Investigator.
Key exclusion criteria (6 listed)
- Resting peripheral oxygen saturation (SpO2) < 92%
- hospitalization or clinical instability during the last four weeks
- treatment with supplementary oxygen at rest or during exercise
- contraindication to exercise testing in accordance with clinical practice guidelines
- expected survival shorter than six months as judged by the Investigator
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 |
|---|---|---|
| L-menthol(Sigma-Aldrich, St. Louis, US) | Drug | Menthol |
| PlaceboStrawberry scent (Sigma-Aldrich, St. Louis, US) | Other | Placebo |
Primary outcome
Breathlessness intensity
Time frame: Through study completion, up to 1 year
The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.
18 secondary outcomes
Dyspnea unpleasantness
Time frame: Through study completion, up to 1 year
Total time
Time frame: Through study completion, up to 1 year
Exercise capacity
Time frame: Through study completion, up to 1 year
Work load
Time frame: Through study completion, up to 1 year
Minute ventilation
Time frame: Through study completion, up to 1 year
Tidal volume (VT)
Time frame: Through study completion, up to 1 year
Ventilatory reserve
Time frame: Through study completion, up to 1 year
Cardiac reserve
Time frame: Through study completion, up to 1 year
Inspiratory capacity
Time frame: Through study completion, up to 1 year
Breathing frequency
Time frame: Through study completion, up to 1 year
Peak dyspnea intensity
Time frame: Through study completion, up to 1 year
Leg discomfort
Time frame: Through study completion, up to 1 year
Anaerobic threshold
Time frame: Through study completion, up to 1 year
Ventilatory efficacy
Time frame: Through study completion, up to 1 year
Respiratory exchange ratio
Time frame: Through study completion, up to 1 year
Saturation
Time frame: Through study completion, up to 1 year
Stop reason
Time frame: Through study completion, up to 1 year
Adverse events
Time frame: Through study completion, up to 1 year
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 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Zainab Ahmadi, MD, PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-menthol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Region Skane at 1 site in Sweden.
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 5 inclusion and 6 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Breathlessness intensity (time frame: Through study completion, up to 1 year). 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 9 Dec 2025.