Menthol for Dyspnea Relief in Health and COPD
MENTHODYSC
Effectiveness and Mechanisms of Menthol Inhalation for the Relief of Dyspnea in Health and COPD
1 other identifier
interventional
120
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2028
November 19, 2025
November 1, 2025
5.8 years
February 7, 2023
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 week
Other Outcomes (12)
Difference in diaphragmatic electromyography with menthol vs. strawberry.
1 week
Difference in dyspnea with menthol vs. strawberry (+ facial airflow or airflow to leg in WP5).
1 week
Difference in the rate of perceived inspiratory airflow.
1 week
- +9 more other outcomes
Study Arms (13)
WP 1a
EXPERIMENTALMenthol inhalation during resistive loaded breathing trials in healthy participants.
WP 1b
PLACEBO COMPARATORStrawberry scent during resistive loaded breathing trials in healthy participants.
WP 2a
EXPERIMENTALMenthol inhalation during cycle exercise in healthy participants.
WP 2b
PLACEBO COMPARATORStrawberry scent during cycle exercise in healthy participants.
WP 3a
EXPERIMENTALMenthol inhalation during resting breathing in dyspneic COPD participants.
WP 3b
PLACEBO COMPARATORStrawberry scent during resting breathing in dyspneic COPD participants.
WP 3c
NO INTERVENTIONResting breathing in dyspneic COPD participants.
WP 4a
EXPERIMENTALMenthol inhalation during cycle exercise in COPD participants.
WP 4b
PLACEBO COMPARATORStrawberry scent during cycle exercise in COPD participants.
WP 5a
EXPERIMENTALMenthol inhalation and facial airflow during cycle exercise in COPD participants
WP 5b
PLACEBO COMPARATORStrawberry inhalation and airflow to leg during cycle exercise in COPD participants
WP 5c
PLACEBO COMPARATORMenthol inhalation and airflow to leg during cycle exercise in COPD patients
WP 5d
PLACEBO COMPARATORStrawberry inhalation and facial airflow during cycle exercise in COPD patients
Interventions
300 milligrams of L-menthol will be deposited on to a cellulose swab and secured inside the lower portion of a sealed facemask.
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 will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
Strawberry will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.
Menthol will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.
Strawberry will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
University Hospital Leuven
Leuven, 3000, Belgium
Related Publications (1)
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.
PMID: 40088943DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Langer
KU Leuven
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 7, 2023
First Posted
March 27, 2023
Study Start
January 1, 2023
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
October 31, 2028
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share