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Completed

NCT Number: NCT05888597

Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-menthol

Drug

(Sigma-Aldrich, St. Louis, US)

Placebo

Other

Strawberry scent (Sigma-Aldrich, St. Louis, US)

Primary outcomes

  1. Breathlessness intensity

    Time frame: Through study completion, up to 1 year

    The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.

Secondary outcomes

  1. Dyspnea unpleasantness

    Time frame: Through study completion, up to 1 year

    The difference between treatment conditions in dyspnea unpleasantness (Borg CR10 scale) at iso-time.

  2. Total time

    Time frame: Through study completion, up to 1 year

    Time to the limit of tolerance (s) (tLIM)

  3. Exercise capacity

    Time frame: Through study completion, up to 1 year

    V'O2 (aerobic exercise capacity, absolute and in %pred)

  4. Work load

    Time frame: Through study completion, up to 1 year

    Workload (W and %pred)

  5. Minute ventilation

    Time frame: Through study completion, up to 1 year

    Minute ventilation

  6. Tidal volume (VT)

    Time frame: Through study completion, up to 1 year

    Tidal volume (VT)

  7. Ventilatory reserve

    Time frame: Through study completion, up to 1 year

    Ventilatory reserve, defined as maximal voluntary ventilation (MVV) - VE

  8. Cardiac reserve

    Time frame: Through study completion, up to 1 year

    Cardiac reserve, evaluated using the predicted peak heart rate

  9. Inspiratory capacity

    Time frame: Through study completion, up to 1 year

    Inspiratory capacity (IC) during exercise

  10. Breathing frequency

    Time frame: Through study completion, up to 1 year

    Breathing frequency during exercise

  11. Peak dyspnea intensity

    Time frame: Through study completion, up to 1 year

    Dyspnea intensity at peak exercise (Borg CR10)

  12. Leg discomfort

    Time frame: Through study completion, up to 1 year

    Leg discomfort (Borg CR10)

  13. Anaerobic threshold

    Time frame: Through study completion, up to 1 year

    Timing (and V'O2) of the anaerobic threshold (AT)

  14. Ventilatory efficacy

    Time frame: Through study completion, up to 1 year

    Efficacy of ventilation (VE/V'CO2-slope)

  15. Respiratory exchange ratio

    Time frame: Through study completion, up to 1 year

    Respiratory exchange ratio (RER), defined as V'CO2/V'O2

  16. Saturation

    Time frame: Through study completion, up to 1 year

    O2-saturation

  17. Stop reason

    Time frame: Through study completion, up to 1 year

    Causes of stopping the test

  18. Adverse events

    Time frame: Through study completion, up to 1 year

    Any adverse events during the test

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

Effect of L-menthol on Breathlessness and Exercise Capacity in Chronic Obstructive Pulmonary Disease: a Randomized

Acronym: Ment-COPD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2023
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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