Menthol for Dyspnea Relief in Health and COPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKU Leuven
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Menthol inhalation
Other intervention300 milligrams of L-menthol will be deposited on to a cellulose swab and secured inside the lower portion of a sealed facemask.
Strawberry scent
Other intervention600 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 inhalation and facial airflow
Other interventionMenthol will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
Strawberry scent and airflow to leg
Other interventionStrawberry will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.
Menthol inhalation and airflow to leg
Other interventionMenthol will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.
Strawberry inhalation and facial airflow
Other interventionStrawberry will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
Treatment groups
120 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Group A: WP 1aExperimental treatment 1 intervention
Group B: WP 1bPlacebo comparator 1 intervention
Group C: WP 2aExperimental treatment 1 intervention
Group D: WP 2bPlacebo comparator 1 intervention
Group E: WP 3aExperimental treatment 1 intervention
Group F: WP 3bPlacebo comparator 1 intervention
Group G: WP 3cNo intervention 0 interventions
Group H: WP 4aExperimental treatment 1 intervention
Group I: WP 4bPlacebo comparator 1 intervention
Group J: WP 5aExperimental treatment 1 intervention
Group K: WP 5bPlacebo comparator 1 intervention
Group L: WP 5cPlacebo comparator 1 intervention
Group M: WP 5dPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in respiratory-related evoked potentials (RREP) with menthol vs. strawberry.
RREPs will be measured using an electroencephalogram (EEG) sensor cap connected to a high-density 129 channel EEG system during breathing trials and exercise tests. Inspiration will briefly be interrupted for 150 milliseconds every two to six breaths by activation of the occluder, which induces the RREP in the EEG signal.
Time frame
1 weekOther outcomes
1
Difference in diaphragmatic electromyography with menthol vs. strawberry.
Diaphragmatic electromyography will be measured using a multi-pair electrode catheter during breathing trials and exercise tests. and used as an index of neural respiratory drive.
Time frame
1 week2
Difference in dyspnea with menthol vs. strawberry (+ facial airflow or airflow to leg in WP5).
Dyspnea ratings will be measured using the Borg 0-10 category ratio scale and will be assessed at the end of each 5-minute breathing trial (WP1 and 3), and at baseline, every minute during (WP4,5) or halfway through the test (WP2), and at peak of each cycle exercise test. 0 represents no dyspnea at all and then 10 the most maximal dyspnea ever experienced or could be imagined experiencing.
Time frame
1 week3
Difference in the rate of perceived inspiratory airflow.
Participants will be asked: "In which of the four conditions did your airflow feel easier when breathing in?" at the end of each study visit.
Time frame
1 week4
Perception of a cooling sensation.
Participants will be asked: "In which of the four conditions did you feel a fresh or cooling sensation when breathing in?" at the end of each study visit.
Time frame
1 week Source ClinicalTrials.gov