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NCT Number: NCT07398287

Efficacy of L-menthol on Breathlessness in Interstitial Lung Disease

The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Interstitial lung disease (ILD).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blekinge Institute of Technology, Karlskrona, Blekinge County, Sweden

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About this study

Dyspnea is a cardinal symptom in patients with interstitial lung disease (ILD), often triggered by daily-life physical activities. 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 ILD 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 ILD.

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
  • Physician diagnosis of fibrosing ILD according to international guidelines
  • age 18 years or older
  • able to cycle
  • able to understand and talk Swedish to participate in the study procedures, as judged by the Investigators.

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: During submaximal test, at isotime during day 2 and day 3.

    The difference between treatment conditions in dyspnea intensity at iso-time. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived breathlessness at all, and 10 represents maximum breathlessness intensity ever experienced.

Secondary outcomes

  1. Dyspnea unpleasantness

    Time frame: During submaximal test, at iso-time during day 2 and day 3.

    The difference between treatment conditions in dyspnea unpleasantness at iso-time. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived unpleasantness at all, and 10 represents maximum breathlessness unpleasantness ever experienced.

  2. Total time

    Time frame: At the end of submaximal test during day 2 and day 3.

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

  3. Exercise capacity

    Time frame: Submaximal test during day 2 and day 3.

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

  4. Peak dyspnea intensity

    Time frame: During submaximal test, at peak during day 2 and day 3.

    Dyspnea intensity at peak exercise. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived breathlessness at all, and 10 represents maximum breathlessness intensity ever experienced.

  5. Leg fatigue

    Time frame: During submaximal test at day 2 and day 3.

    Leg fatigue. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived leg fatigue at all, and 10 represents maximum leg fatigue ever experienced.

  6. Ventilatory efficacy

    Time frame: During submaximal test at day 2 and day 3.

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

  7. Saturation

    Time frame: During submaximal test at day 2 and day 3.

    O2-Saturation

  8. Stop reason

    Time frame: During submaximal test at day 2 and day 3.

    Causes of stopping the test

  9. Adverse events

    Time frame: through study completion, an average of 1 week.

    Any adverse events during the test

  10. Respiratory exchange ratio

    Time frame: During the submaximal test at day 2 and day 3.

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

  11. Heart rate

    Time frame: During the submaximal test at day 2 and day 3.

    Heart rate in beats/min

  12. Breathing frequency

    Time frame: During the submaximal test at day 2 and day 3.

    Breathing frequency in breaths/min

  13. Minute ventilation

    Time frame: During the submaximal test at day 2 and day 3.

    Minute ventilation

  14. Tidal volume (VT)

    Time frame: During the submaximal test at day 2 and day 3.

    Tidal volume in liters

  15. Ventilatory reserve

    Time frame: During the submaximal test at day 2 and day 3.

    defined as maximal voluntary ventilation (MVV) - VE

Study contacts

Contact information is provided by the study sponsor or research team.

Zainab Ahmadi, MD, PhD

CONTACT

[email protected]

046171000

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Blekinge Institute of Technology
  • Blekingesjukhuset, Karlskrona
  • Lund University

Registry information

Official study title

Effect of L-menthol on Breathlessness and Exercise Capacity in Interstitial Lung Disease: a Randomized Crossover Trial

Acronym: Ment-ILD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Apr 24, 2026

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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