Menthol for Dyspnea Relief in Health and COPD
Effectiveness and Mechanisms of Menthol Inhalation for the Relief of Dyspnea in Health and COPD
KU Leuven
120 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria11
- 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
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05785026