Menthol for Dyspnea Relief in Health and COPD
Recruiting · NCT05785026 · Interventional (participants receive a specific treatment) · Lead sponsor: KU Leuven
View the official record on ClinicalTrials.gov →Interventions studied
Menthol inhalationMenthol inhalation and airflow to legMenthol inhalation and facial airflowStrawberry inhalation and facial airflowStrawberry scentStrawberry scent and airflow to leg
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- University Hospital Leuven - Leuven, Belgium