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Clinical Trials in Belgium / NCT05785026
Recruiting Not applicable

Menthol for Dyspnea Relief in Health and COPD

NCT05785026 · tracked via the Priya Life Science Belgium tracker
Sponsor
KU Leuven
Phase
Not applicable
Started
2023-01-01
Last updated
2025-11-19

Condition(s) studied

DyspneaChronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Menthol inhalationStrawberry scentMenthol inhalation and facial airflowStrawberry scent and airflow to legMenthol inhalation and airflow to legStrawberry inhalation and facial airflow

Menthol inhalation: 300 milligrams of L-menthol will be deposited on to a cellulose swab and secured inside the lower portion of a sealed facemask.

Strawberry scent: 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 airflow: Menthol will be administered using a noseplug and facial airflow will be applied with a tabletop fan.

Strawberry scent and airflow to leg: Strawberry will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.

Menthol inhalation and airflow to leg: Menthol will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.

Strawberry inhalation and facial airflow: Strawberry will be administered using a noseplug and facial airflow will be applied with a tabletop fan.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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) Exclusion Criteria: * 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

Primary outcome measure(s)

  • Difference in respiratory-related evoked potentials (RREP) with menthol vs. strawberry. — 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.

Trial sites (1)

FacilityCityRegionStatus
University Hospital Leuven Leuven Belgium Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05785026 on ClinicalTrials.gov ↗ ← All trials in Belgium