DyspneaMENTHODYSCNCT05785026
Menthol for Dyspnea Relief in Health and COPD
A study testing Menthol inhalation, Strawberry scent and Menthol inhalation and facial airflow in people with Dyspnea and Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
Trial summary
Menthol inhalation (MI) is a novel and promising treatment option for acute relief of dyspnea, however, the underlying ventilatory and/or neural related mechanisms for this relief in symptoms remain unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyspnea, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Menthol inhalation, Strawberry scent and Menthol inhalation and facial airflow
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2023to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 years of age or older
- Able to speak, read, and write Dutch or English
- Normal pulmonary function: forced expiratory volume in 1 second (FEV1) to forced vital capacity ratio>0.70; FEV1≥80%predicted (WP1 and 2 only)
- Non-smoker or former smokers (smoke-free ≥12 months prior to enrolment) (WP1 and 2 only)
- Clinically stable COPD (based on clinical judgment of the study physician that have not had exacerbations requiring escalation of medical therapy (i.e., short course of oral corticosteroids or antibiotics) within the preceding 14 days (WP3 and 4 only)
Who cannot join
- Contraindication to exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease; see Table 4 from ERS/ATS consensus statement)
- Significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could influence dyspnea and/or impair exercise capacity (with the exception of COPD in WP3 and 4)
- Body mass index <18.5 or >35 kg/m2
- An ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery
- Severe facial trauma including cribriform plate disruption (bone separating brain from nasal cavity)
- Allergies to latex and sensitivities to local anesthetics
Show all 11Show fewer
- Inability to give informed consent, including those with significant cognitive impairment
- Alcohol consumption within 12 hours of study visit
- Current smoker*
- History of early menopause (age <45 years)
- Pregnancy or desire to become pregnant while in trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Leuven
Leuven, 3000
Daniel Langer, daniel.langer@kuleuven.be
Daniel Langer
About this study
Official title: Effectiveness and Mechanisms of Menthol Inhalation for the Relief of Dyspnea in Health and COPD
Menthol inhalation (MI) is a novel and promising treatment option for acute relief of dyspnea, however, the underlying ventilatory and/or neural related mechanisms for this relief in symptoms remain unknown. The overall aim of this research project is to systematically examine the mechanisms of dyspnea relief from MI in healthy individuals and those with COPD.
Read the detailed description
The project is structured in 5 work packages (WP), each including a different sample of healthy volunteers (WP1, 2) or patients with COPD (WP3, 4, 5), respectively with a 1:1 female/male ratio in each WP. Each WP will be single-blind, placebo-controlled cross-over trial to investigate the effects of MI compared to placebo in healthy volunteers during resistive loaded breathing (WP1), in healthy volunteers during cycling exercise (WP2), in people with COPD who have dyspnea at rest (WP3), and in people with COPD during cycling exercise (WP4, 5).
- Conditions
- Dyspnea, Chronic Obstructive Pulmonary Disease
- Being tested
- Menthol inhalation, Strawberry scent, Menthol inhalation and facial airflow, Strawberry scent and airflow to leg, Menthol inhalation and airflow to leg
- Keywords
- Menthol
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol inhalationOther
300 milligrams of L-menthol will be deposited on to a cellulose swab and secured inside the lower portion of a sealed facemask.
Strawberry scentOther
600 microliters of 100% natural strawberry flavoring will be deposited onto on to a cellulose swab and secured inside the lower portion of a sealed facemask.
Menthol inhalation and facial airflowOther
Menthol will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
Strawberry scent and airflow to legOther
Strawberry will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.
Menthol inhalation and airflow to legOther
Menthol will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.
Strawberry inhalation and facial airflowOther
Strawberry will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
| Study group | Role | What they receive |
|---|---|---|
| WP 1a | Experimental | Menthol inhalation during resistive loaded breathing trials in healthy participants. Receives: Other: Menthol inhalation |
| WP 1b | Placebo comparator | Strawberry scent during resistive loaded breathing trials in healthy participants. Receives: Other: Strawberry scent |
| WP 2a | Experimental | Menthol inhalation during cycle exercise in healthy participants. Receives: Other: Menthol inhalation |
| WP 2b | Placebo comparator | Strawberry scent during cycle exercise in healthy participants. Receives: Other: Strawberry scent |
| WP 3a | Experimental | Menthol inhalation during resting breathing in dyspneic COPD participants. Receives: Other: Menthol inhalation |
| WP 3b | Placebo comparator | Strawberry scent during resting breathing in dyspneic COPD participants. Receives: Other: Strawberry scent |
| WP 3c | No intervention | Resting breathing in dyspneic COPD participants. |
| WP 4a | Experimental | Menthol inhalation during cycle exercise in COPD participants. Receives: Other: Menthol inhalation |
| WP 4b | Placebo comparator | Strawberry scent during cycle exercise in COPD participants. Receives: Other: Strawberry scent |
| WP 5a | Experimental | Menthol inhalation and facial airflow during cycle exercise in COPD participants Receives: Other: Menthol inhalation and facial airflow |
| WP 5b | Placebo comparator | Strawberry inhalation and airflow to leg during cycle exercise in COPD participants Receives: Other: Strawberry scent and airflow to leg |
| WP 5c | Placebo comparator | Menthol inhalation and airflow to leg during cycle exercise in COPD patients Receives: Other: Menthol inhalation and airflow to leg |
| WP 5d | Placebo comparator | Strawberry inhalation and facial airflow during cycle exercise in COPD patients Receives: Other: Strawberry inhalation and facial airflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in respiratory-related evoked potentials (RREP) with menthol vs. strawberry.
RREPs will be measured using an electroencephalogram (EEG) sensor cap connected to a high-density 129 channel EEG system during breathing trials and exercise tests. Inspiration will briefly be interrupted for 150 milliseconds every two to six breaths by activation of the occluder, which induces the RREP in the EEG signal.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jan 2023
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Langer, KU Leuven
- Investigators
- Daniel Langer, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785026
- Sponsor's protocol ID
- S66762
- Acronym
- MENTHODYSC
- Status last verified
- Nov 2025
- First submitted
- 7 Feb 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schaeffer MR, Vanden Bossche L, Beckers K, Verbeke K, Janssens W, Jensen D, Arnold JI, von Leupoldt A, Langer D. Inhaled Menthol for Dyspnea Relief During Cycle Exercise in COPD: A Randomized Trial. Chest. 2025 Aug;168(2):390-401. doi: 10.1016/j.chest.2025.03.002. Epub 2025 Mar 13.
PubMed 40088943
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Mechanisms of Menthol Inhalation for the Relief of Dyspnea in Health and COPD
- ClinicalTrials.gov ID
- NCT05785026
- Acronym / sponsor ID
- MENTHODYSC / S66762
- Conditions
- Dyspnea, Chronic Obstructive Pulmonary Disease
- Keywords
- Menthol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 27 Mar 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.
Menthol inhalation (MI) is a novel and promising treatment option for acute relief of dyspnea, however, the underlying ventilatory and/or neural related mechanisms for this relief in symptoms remain unknown. The overall aim of this research project is to systematically examine the mechanisms of dyspnea relief from MI in healthy individuals and those with COPD.
Detailed description
The project is structured in 5 work packages (WP), each including a different sample of healthy volunteers (WP1, 2) or patients with COPD (WP3, 4, 5), respectively with a 1:1 female/male ratio in each WP. Each WP will be single-blind, placebo-controlled cross-over trial to investigate the effects of MI compared to placebo in healthy volunteers during resistive loaded breathing (WP1), in healthy volunteers during cycling exercise (WP2), in people with COPD who have dyspnea at rest (WP3), and in people with COPD during cycling exercise (WP4, 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| WP 1a | Experimental | Other: Menthol inhalationMenthol inhalation during resistive loaded breathing trials in healthy participants. |
| WP 1b | Placebo comparator | Other: Strawberry scentStrawberry scent during resistive loaded breathing trials in healthy participants. |
| WP 2a | Experimental | Other: Menthol inhalationMenthol inhalation during cycle exercise in healthy participants. |
| WP 2b | Placebo comparator | Other: Strawberry scentStrawberry scent during cycle exercise in healthy participants. |
| WP 3a | Experimental | Other: Menthol inhalationMenthol inhalation during resting breathing in dyspneic COPD participants. |
| WP 3b | Placebo comparator | Other: Strawberry scentStrawberry scent during resting breathing in dyspneic COPD participants. |
| WP 3c | No intervention | –Resting breathing in dyspneic COPD participants. |
| WP 4a | Experimental | Other: Menthol inhalationMenthol inhalation during cycle exercise in COPD participants. |
| WP 4b | Placebo comparator | Other: Strawberry scentStrawberry scent during cycle exercise in COPD participants. |
| WP 5a | Experimental | Other: Menthol inhalation and facial airflowMenthol inhalation and facial airflow during cycle exercise in COPD participants |
| WP 5b | Placebo comparator | Other: Strawberry scent and airflow to legStrawberry inhalation and airflow to leg during cycle exercise in COPD participants |
| WP 5c | Placebo comparator | Other: Menthol inhalation and airflow to legMenthol inhalation and airflow to leg during cycle exercise in COPD patients |
| WP 5d | Placebo comparator | Other: Strawberry inhalation and facial airflowStrawberry inhalation and facial airflow during cycle exercise in COPD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 years of age or older
- Able to speak, read, and write Dutch or English
- Normal pulmonary function: forced expiratory volume in 1 second (FEV1) to forced vital capacity ratio>0.70; FEV1≥80%predicted (WP1 and 2 only)
- Non-smoker or former smokers (smoke-free ≥12 months prior to enrolment) (WP1 and 2 only)
- Clinically stable COPD (based on clinical judgment of the study physician that have not had exacerbations requiring escalation of medical therapy (i.e., short course of oral corticosteroids or antibiotics) within the preceding 14 days (WP3 and 4 only)
Key exclusion criteria (11 listed)
- Contraindication to exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease; see Table 4 from ERS/ATS consensus statement)
- Significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could influence dyspnea and/or impair exercise capacity (with the exception of COPD in WP3 and 4)
- Body mass index <18.5 or >35 kg/m2
- An ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery
- Severe facial trauma including cribriform plate disruption (bone separating brain from nasal cavity)
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 |
|---|---|---|
| Menthol inhalation300 milligrams of L-menthol will be deposited on to a cellulose swab and secured inside the lower portion of a sealed facemask. | Other | WP 1a, WP 2a, WP 3a, WP 4a |
| Strawberry scent600 microliters of 100% natural strawberry flavoring will be deposited onto on to a cellulose swab and secured inside the lower portion of a sealed facemask. | Other | WP 1b, WP 2b, WP 3b, WP 4b |
| Menthol inhalation and facial airflowMenthol will be administered using a noseplug and facial airflow will be applied with a tabletop fan. | Other | WP 5a |
| Strawberry scent and airflow to legStrawberry will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan. | Other | WP 5b |
| Menthol inhalation and airflow to legMenthol will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan. | Other | WP 5c |
| Strawberry inhalation and facial airflowStrawberry will be administered using a noseplug and facial airflow will be applied with a tabletop fan. | Other | WP 5d |
Primary outcome
Difference in respiratory-related evoked potentials (RREP) with menthol vs. strawberry.
Time frame: 1 week
RREPs will be measured using an electroencephalogram (EEG) sensor cap connected to a high-density 129 channel EEG system during breathing trials and exercise tests. Inspiration will briefly be interrupted for 150 milliseconds every two to six breaths by activation of the occluder, which induces the RREP in the EEG signal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 40088943Schaeffer MR, Vanden Bossche L, Beckers K, Verbeke K, Janssens W, Jensen D, Arnold JI, von Leupoldt A, Langer D. Inhaled Menthol for Dyspnea Relief During Cycle Exercise in COPD: A Randomized Trial. Chest. 2025 Aug;168(2):390-401. doi: 10.1016/j.chest.2025.03.002. Epub 2025 Mar 13.
- 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.
Daniel Langer principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol inhalation, Strawberry scent and Menthol inhalation and facial airflow in people with Dyspnea and Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
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 11 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: looking for participants now, as of the sponsor's last update on 19 Nov 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Langer (+32 16 37 64 97, daniel.langer@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in respiratory-related evoked potentials (RREP) with menthol vs. strawberry. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05785026, which also lists 1 linked publication.
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 19 Nov 2025.