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| Name | Class |
|---|---|
| Lund University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menthol | Experimental | 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. |
|
| Placebo | Placebo Comparator | For placebo, the patch will contain a similarly patch with strawberry scent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-menthol | Drug | (Sigma-Aldrich, St. Louis, US) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Breathlessness intensity | The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time. | Through study completion, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea unpleasantness | The difference between treatment conditions in dyspnea unpleasantness (Borg CR10 scale) at iso-time. | Through study completion, up to 1 year |
| Total time | Time to the limit of tolerance (s) (tLIM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zainab Ahmadi, MD, PhD | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lund University | Lund | Sweden |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2025 | Dec 1, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D008610 | Menthol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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Multi-center, randomized (ratio 1:1), double-blinded, placebo-controlled, crossover trial (RCT) design
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| Other |
Strawberry scent (Sigma-Aldrich, St. Louis, US) |
|
| Through study completion, up to 1 year |
| Exercise capacity | V'O2 (aerobic exercise capacity, absolute and in %pred) | Through study completion, up to 1 year |
| Work load | Workload (W and %pred) | Through study completion, up to 1 year |
| Minute ventilation | Minute ventilation | Through study completion, up to 1 year |
| Tidal volume (VT) | Tidal volume (VT) | Through study completion, up to 1 year |
| Ventilatory reserve | Ventilatory reserve, defined as maximal voluntary ventilation (MVV) - VE | Through study completion, up to 1 year |
| Cardiac reserve | Cardiac reserve, evaluated using the predicted peak heart rate | Through study completion, up to 1 year |
| Inspiratory capacity | Inspiratory capacity (IC) during exercise | Through study completion, up to 1 year |
| Breathing frequency | Breathing frequency during exercise | Through study completion, up to 1 year |
| Peak dyspnea intensity | Dyspnea intensity at peak exercise (Borg CR10) | Through study completion, up to 1 year |
| Leg discomfort | Leg discomfort (Borg CR10) | Through study completion, up to 1 year |
| Anaerobic threshold | Timing (and V'O2) of the anaerobic threshold (AT) | Through study completion, up to 1 year |
| Ventilatory efficacy | Efficacy of ventilation (VE/V'CO2-slope) | Through study completion, up to 1 year |
| Respiratory exchange ratio | Respiratory exchange ratio (RER), defined as V'CO2/V'O2 | Through study completion, up to 1 year |
| Saturation | O2-saturation | Through study completion, up to 1 year |
| Stop reason | Causes of stopping the test | Through study completion, up to 1 year |
| Adverse events | Any adverse events during the test | Through study completion, up to 1 year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |