Using menthol to relieve breathing difficulties in healthy individuals and COPD patients
Effectiveness and Mechanisms of Menthol Inhalation for the Relief of Dyspnea in Health and COPD
This study is testing if inhaling menthol can help relieve breathing difficulties in both healthy people and those with COPD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05785026 on ClinicalTrials.gov |
What this trial studies
This research investigates the effects of menthol inhalation on relieving dyspnea in both healthy individuals and patients with Chronic Obstructive Pulmonary Disease (COPD). The study is divided into four work packages, each focusing on different participant groups, including healthy volunteers and COPD patients, using a single-blind, placebo-controlled cross-over design. Participants will undergo various breathing and exercise tests to assess the effectiveness of menthol compared to a placebo. The aim is to understand the mechanisms behind the relief of dyspnea provided by menthol inhalation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stable COPD or healthy individuals with normal pulmonary function.
Not a fit: Patients with significant pulmonary or extra-pulmonary diseases that could affect dyspnea or exercise capacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective way to alleviate breathing difficulties for patients with COPD.
How similar studies have performed: While menthol inhalation is a novel approach, similar studies exploring alternative methods for dyspnea relief have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leuven
- University Hospital Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Daniel Langer — KU Leuven
- Study coordinator: Daniel Langer
- Email: daniel.langer@kuleuven.be
- Phone: +32 16 37 64 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.