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RECRUITINGINTERVENTIONAL

Menthol for Dyspnea Relief in Health and COPD

Effectiveness and Mechanisms of Menthol Inhalation for the Relief of Dyspnea in Health and COPD

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 willing to sign a consent form, 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

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.

OTHER

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.

OTHER

Menthol inhalation and facial airflow

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

OTHER

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.

OTHER

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.

OTHER

Strawberry inhalation and facial airflow

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

Locations (1)

University Hospital Leuven
Leuven, Belgium