The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
Lund University
Lund, Sweden
Breathlessness intensity
The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.
Time frame: Through study completion, up to 1 year
Dyspnea unpleasantness
The difference between treatment conditions in dyspnea unpleasantness (Borg CR10 scale) at iso-time.
Time frame: Through study completion, up to 1 year
Total time
Time to the limit of tolerance (s) (tLIM)
Time frame: Through study completion, up to 1 year
Exercise capacity
V'O2 (aerobic exercise capacity, absolute and in %pred)
Time frame: Through study completion, up to 1 year
Work load
Workload (W and %pred)
Time frame: Through study completion, up to 1 year
Minute ventilation
Minute ventilation
Time frame: Through study completion, up to 1 year
Tidal volume (VT)
Tidal volume (VT)
Time frame: Through study completion, up to 1 year
Ventilatory reserve
Ventilatory reserve, defined as maximal voluntary ventilation (MVV) - VE
Time frame: Through study completion, up to 1 year
Cardiac reserve
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Cardiac reserve, evaluated using the predicted peak heart rate
Time frame: Through study completion, up to 1 year
Inspiratory capacity
Inspiratory capacity (IC) during exercise
Time frame: Through study completion, up to 1 year
Breathing frequency
Breathing frequency during exercise
Time frame: Through study completion, up to 1 year
Peak dyspnea intensity
Dyspnea intensity at peak exercise (Borg CR10)
Time frame: Through study completion, up to 1 year
Leg discomfort
Leg discomfort (Borg CR10)
Time frame: Through study completion, up to 1 year
Anaerobic threshold
Timing (and V'O2) of the anaerobic threshold (AT)
Time frame: Through study completion, up to 1 year
Ventilatory efficacy
Efficacy of ventilation (VE/V'CO2-slope)
Time frame: Through study completion, up to 1 year
Respiratory exchange ratio
Respiratory exchange ratio (RER), defined as V'CO2/V'O2
Time frame: Through study completion, up to 1 year
Saturation
O2-saturation
Time frame: Through study completion, up to 1 year
Stop reason
Causes of stopping the test
Time frame: Through study completion, up to 1 year
Adverse events
Any adverse events during the test
Time frame: Through study completion, up to 1 year