Lund University
Lund, Sweden
NCT Number: NCT05888597
The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD).
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Lund, Sweden
Breathelssness (Dyspnea) is a cardinal symptom in patients with chronic obstructive pulmonary disease (COPD), often triggered by daily-life physical activities. Despite optimal treatment of the underlying disease, many patients still suffer from chronic and disabling dyspnea for many years, leading to exercise intolerance, and worse morbidity and mortality. 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 COPD 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 COPD.
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: Through study completion, up to 1 year
The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.
Time frame: Through study completion, up to 1 year
The difference between treatment conditions in dyspnea unpleasantness (Borg CR10 scale) at iso-time.
Time frame: Through study completion, up to 1 year
Time to the limit of tolerance (s) (tLIM)
Time frame: Through study completion, up to 1 year
V'O2 (aerobic exercise capacity, absolute and in %pred)
Time frame: Through study completion, up to 1 year
Workload (W and %pred)
Time frame: Through study completion, up to 1 year
Minute ventilation
Time frame: Through study completion, up to 1 year
Tidal volume (VT)
Time frame: Through study completion, up to 1 year
Ventilatory reserve, defined as maximal voluntary ventilation (MVV) - VE
Time frame: Through study completion, up to 1 year
Cardiac reserve, evaluated using the predicted peak heart rate
Time frame: Through study completion, up to 1 year
Inspiratory capacity (IC) during exercise
Time frame: Through study completion, up to 1 year
Breathing frequency during exercise
Time frame: Through study completion, up to 1 year
Dyspnea intensity at peak exercise (Borg CR10)
Time frame: Through study completion, up to 1 year
Leg discomfort (Borg CR10)
Time frame: Through study completion, up to 1 year
Timing (and V'O2) of the anaerobic threshold (AT)
Time frame: Through study completion, up to 1 year
Efficacy of ventilation (VE/V'CO2-slope)
Time frame: Through study completion, up to 1 year
Respiratory exchange ratio (RER), defined as V'CO2/V'O2
Time frame: Through study completion, up to 1 year
O2-saturation
Time frame: Through study completion, up to 1 year
Causes of stopping the test
Time frame: Through study completion, up to 1 year
Any adverse events during the test
Region Skane
Other
Effect of L-menthol on Breathlessness and Exercise Capacity in Chronic Obstructive Pulmonary Disease: a Randomized
Acronym: Ment-COPD
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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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