Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-01-01
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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WP 1a
Menthol inhalation during resistive loaded breathing trials in healthy participants.
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.
WP 1b
Strawberry scent during resistive loaded breathing trials in healthy participants.
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.
WP 2a
Menthol inhalation during cycle exercise in healthy participants.
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.
WP 2b
Strawberry scent during cycle exercise in healthy participants.
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.
WP 3a
Menthol inhalation during resting breathing in dyspneic COPD participants.
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.
WP 3b
Strawberry scent during resting breathing in dyspneic COPD participants.
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.
WP 3c
Resting breathing in dyspneic COPD participants.
No interventions assigned to this group
WP 4a
Menthol inhalation during cycle exercise in COPD participants.
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.
WP 4b
Strawberry scent during cycle exercise in COPD participants.
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.
WP 5a
Menthol inhalation and facial airflow during cycle exercise in COPD participants
Menthol inhalation and facial airflow
Menthol will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
WP 5b
Strawberry inhalation and airflow to leg during cycle exercise in COPD participants
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.
WP 5c
Menthol inhalation and airflow to leg during cycle exercise in COPD patients
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.
WP 5d
Strawberry inhalation and facial airflow during cycle exercise in COPD patients
Strawberry inhalation and facial airflow
Strawberry will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
Interventions
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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.
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.
Menthol inhalation and facial airflow
Menthol will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
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.
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.
Strawberry inhalation and facial airflow
Strawberry will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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KU Leuven
OTHER
Responsible Party
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Daniel Langer
Assistant Professor
Principal Investigators
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Daniel Langer
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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University Hospital Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Schaeffer MR, Vanden Bossche L, Beckers K, Verbeke K, Janssens W, Jensen D, Arnold JI, von Leupoldt A, Langer D. Inhaled Menthol for Dyspnea Relief During Cycle Exercise in COPD: A Randomized Trial. Chest. 2025 Aug;168(2):390-401. doi: 10.1016/j.chest.2025.03.002. Epub 2025 Mar 13.
Other Identifiers
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S66762
Identifier Type: -
Identifier Source: org_study_id
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