Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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.
Interventions
DRUGL-menthol
(Sigma-Aldrich, St. Louis, US)
OTHERPlacebo
Strawberry scent (Sigma-Aldrich, St. Louis, US)
Sponsors
Lund University
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Multi-center, randomized (ratio 1:1), double-blinded, placebo-controlled, crossover trial (RCT) design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathlessness intensity | Through study completion, up to 1 year | The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | Through study completion, up to 1 year | V'O2 (aerobic exercise capacity, absolute and in %pred) |
| Work load | Through study completion, up to 1 year | Workload (W and %pred) |
| Dyspnea unpleasantness | Through study completion, up to 1 year | The difference between treatment conditions in dyspnea unpleasantness (Borg CR10 scale) at iso-time. |
| Minute ventilation | Through study completion, up to 1 year | Minute ventilation |
| Tidal volume (VT) | Through study completion, up to 1 year | Tidal volume (VT) |
| Ventilatory reserve | Through study completion, up to 1 year | Ventilatory reserve, defined as maximal voluntary ventilation (MVV) - VE |
| Cardiac reserve | Through study completion, up to 1 year | Cardiac reserve, evaluated using the predicted peak heart rate |
| Inspiratory capacity | Through study completion, up to 1 year | Inspiratory capacity (IC) during exercise |
| Total time | Through study completion, up to 1 year | Time to the limit of tolerance (s) (tLIM) |
| Peak dyspnea intensity | Through study completion, up to 1 year | Dyspnea intensity at peak exercise (Borg CR10) |
| 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) |
| 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 |
| 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 |
| Breathing frequency | Through study completion, up to 1 year | Breathing frequency during exercise |
Countries
Sweden
Outcome results
None listed