L-menthol
Drug(Sigma-Aldrich, St. Louis, US)
NCT Number: NCT07398287
The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Interstitial lung disease (ILD).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Blekinge Institute of Technology, Karlskrona, Blekinge County, Sweden
Dyspnea is a cardinal symptom in patients with interstitial lung disease (ILD), often triggered by daily-life physical activities. To date, an effective pharmacologic treatment to relieve chronic dyspnea is lacking. Recent pilot data support that inhaled L-menthol can markedly decrease laboratory-induced dyspnea in ILD patients, likely through increased afferent feedback of airflow in the airways by inducing a cooling sensation through olfactory stimulation. The aim of this study is therefore to assess the effectiveness and mechanisms of inhaled menthol for relief of chronic dyspnea in patients with ILD.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(Sigma-Aldrich, St. Louis, US)
Strawberry scent (Sigma-Aldrich, St. Louis, US)
Time frame: During submaximal test, at isotime during day 2 and day 3.
The difference between treatment conditions in dyspnea intensity at iso-time. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived breathlessness at all, and 10 represents maximum breathlessness intensity ever experienced.
Time frame: During submaximal test, at iso-time during day 2 and day 3.
The difference between treatment conditions in dyspnea unpleasantness at iso-time. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived unpleasantness at all, and 10 represents maximum breathlessness unpleasantness ever experienced.
Time frame: At the end of submaximal test during day 2 and day 3.
Time to the limit of tolerance (s) (tLIM)
Time frame: Submaximal test during day 2 and day 3.
V'O2 (aerobic exercise capacity, absolute and in %pred)
Time frame: During submaximal test, at peak during day 2 and day 3.
Dyspnea intensity at peak exercise. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived breathlessness at all, and 10 represents maximum breathlessness intensity ever experienced.
Time frame: During submaximal test at day 2 and day 3.
Leg fatigue. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived leg fatigue at all, and 10 represents maximum leg fatigue ever experienced.
Time frame: During submaximal test at day 2 and day 3.
Efficacy of ventilation (VE/V'CO2-slope)
Time frame: During submaximal test at day 2 and day 3.
O2-Saturation
Time frame: During submaximal test at day 2 and day 3.
Causes of stopping the test
Time frame: through study completion, an average of 1 week.
Any adverse events during the test
Time frame: During the submaximal test at day 2 and day 3.
Respiratory exchange ratio (RER), defined as V'CO2/V'O2
Time frame: During the submaximal test at day 2 and day 3.
Heart rate in beats/min
Time frame: During the submaximal test at day 2 and day 3.
Breathing frequency in breaths/min
Time frame: During the submaximal test at day 2 and day 3.
Minute ventilation
Time frame: During the submaximal test at day 2 and day 3.
Tidal volume in liters
Time frame: During the submaximal test at day 2 and day 3.
defined as maximal voluntary ventilation (MVV) - VE
Contact information is provided by the study sponsor or research team.
Region Skane
Other
Effect of L-menthol on Breathlessness and Exercise Capacity in Interstitial Lung Disease: a Randomized Crossover Trial
Acronym: Ment-ILD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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