Using menthol to relieve breathing difficulties in healthy individuals and COPD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pulmonary and cardiovascular rehabilitation program for chronic respiratory and heart conditions

  This study tests a rehabilitation program that combines exercise for people with chronic lung and heart conditions to see if it helps them feel better and improve their daily activities.

  Recruiting University of Campinas, Brazil · Campinas, São Paulo · NCT06772922

• Improving lung capacity with a breathing device called Lung Master

  This study is testing if using a breathing device called Lung Master can help improve lung capacity and breathing in healthy adults aged 19-35 and those 65 and older.

  Recruiting University of Nebraska · Omaha, Nebraska · NCT06524856

• SELF-BREATHE: a self-guided online program to reduce chronic breathlessness in adults

  This study will test whether SELF-BREATHE, a self-guided internet-based support program, can help adults with chronic breathlessness from lung or heart conditions breathe easier and feel less distressed.

  Recruiting King's College Hospital NHS Trust · London · NCT06326957

• Using tadalafil to relieve shortness of breath in Veterans with COPD and pulmonary hypertension

  This study is testing if tadalafil can help Veterans with COPD and pulmonary hypertension breathe easier and improve their overall health.

  Recruiting at 5 sites Phase 2 VA Office of Research and Development · Aurora, Colorado and 4 other locations · NCT05937854

• Assessing diaphragm function in patients with respiratory diseases

  This study is testing how well the diaphragm works in people with respiratory diseases to see if it affects their breathing difficulties and overall health.

  Recruiting RWTH Aachen University · Aachen, North Rhine-Westphalia · NCT05903001

• Wintergreen oil inhalation for shortness of breath in pneumonia patients

  Hospitals will test whether inhaling wintergreen essential oil helps relieve dyspnea in adults with pneumonia.

  Recruiting Far Eastern Memorial Hospital · New Taipei City, Taipei · NCT07894835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.