Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Other: Placebo
- Registration Number
- NCT05888597
- Lead Sponsor
- Region Skane
- Brief Summary
The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- The subject has given written consent to participate in the study
- Diagnosis of COPD confirmed by spirometry and a FEV1 < 80% of predicted post bronchodilator at baseline
- age 18 years or older
- able to cycle
- able to understand and talk Swedish to participate in the study procedures, as judged by the Investigator.
- Resting peripheral oxygen saturation (SpO2) < 92%
- hospitalization or clinical instability during the last four weeks
- treatment with supplementary oxygen at rest or during exercise
- contraindication to exercise testing in accordance with clinical practice guidelines
- expected survival shorter than six months as judged by the Investigator
- medical conditions including congestive heart failure, acute coronary artery disease, neuromuscular diseases, severe psychiatric illness, and olfaction disorder.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo For placebo, the patch will contain a similarly patch with strawberry scent. Menthol L-menthol In the trial, 30 minutes prior to performing submaximal CPET, participants will be administered, L-menthol patch which will be attached to the inside of a facemask that is connected to the breathing circuit.
- Primary Outcome Measures
Name Time Method Breathlessness intensity Through study completion, up to 1 year The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.
- Secondary Outcome Measures
Name Time Method Tidal volume (VT) Through study completion, up to 1 year Tidal volume (VT)
Cardiac reserve Through study completion, up to 1 year Cardiac reserve, evaluated using the predicted peak heart rate
Leg discomfort Through study completion, up to 1 year Leg discomfort (Borg CR10)
Anaerobic threshold Through study completion, up to 1 year Timing (and V'O2) of the anaerobic threshold (AT)
Stop reason Through study completion, up to 1 year Causes of stopping the test
Adverse events Through study completion, up to 1 year Any adverse events during the test
Dyspnea unpleasantness Through study completion, up to 1 year The difference between treatment conditions in dyspnea unpleasantness (Borg CR10 scale) at iso-time.
Total time Through study completion, up to 1 year Time to the limit of tolerance (s) (tLIM)
Work load Through study completion, up to 1 year Workload (W and %pred)
Exercise capacity Through study completion, up to 1 year V'O2 (aerobic exercise capacity, absolute and in %pred)
Minute ventilation Through study completion, up to 1 year Minute ventilation
Ventilatory reserve Through study completion, up to 1 year Ventilatory reserve, defined as maximal voluntary ventilation (MVV) - VE
Inspiratory capacity Through study completion, up to 1 year Inspiratory capacity (IC) during exercise
Breathing frequency Through study completion, up to 1 year Breathing frequency during exercise
Peak dyspnea intensity Through study completion, up to 1 year Dyspnea intensity at peak exercise (Borg CR10)
Ventilatory efficacy Through study completion, up to 1 year Efficacy of ventilation (VE/V'CO2-slope)
Respiratory exchange ratio Through study completion, up to 1 year Respiratory exchange ratio (RER), defined as V'CO2/V'O2
Saturation Through study completion, up to 1 year O2-saturation
Trial Locations
- Locations (1)
Lund University
🇸🇪Lund, Sweden