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RecruitingNCT07500974Ment-AstmaUpdated Aug 19, 2026

Efficacy of L-menthol on Breathlessness in Asthma

A Phase 2 interventional study of L-menthol and Placebo in Asthma, sponsored by Region Skane. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Region Skane · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Asthma.

Read the detailed description

Dyspnea is a cardinal symptom in patients with lung disease, 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 COPD and 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 patients with Asthma.

02

Conditions studied

  • Asthma

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Keywords

  • breathlessness
  • asthma
  • exercise capacity
  • CPET
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • the subject has given written consent to participate in the study
  • physician diagnosis of Asthma according to international guidelines
  • mMRC (modified Medical Research Council) score of 1 or above
  • 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

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.
04

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    L-menthol

    In the trial, prior to performing submaximal cardio-pulmonary exercise testing (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.

    Drug: L-menthol

  • Placebo comparator
    Placebo

    For placebo, the patch will contain a similarly patch with strawberry scent.

    Other: Placebo

Interventions

  • DrugL-menthol

    (Sigma-Aldrich, St. Louis, US)

  • OtherPlacebo

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

05

What researchers measure

Primary outcomes

  1. Breathlessness intensity

    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.

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

Secondary outcomes

  1. Dyspnea unpleasantness

    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 experienced.

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

  2. Total time

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

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

  3. Exercise capacity

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

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

  4. Peak dyspnea intensity

    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.

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

  5. 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.

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

  6. Ventilatory efficacy

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

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

  7. Saturation

    O2-Saturation

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

  8. Stop reason

    Causes of stopping the test

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

  9. Adverse events

    Any adverse events during the test

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

  10. Respiratory exchange ratio

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

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

  11. Heart rate

    Heart rate in beats/min

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

  12. Breathing frequency

    Breathing frequency in breaths/min

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

  13. Minute ventilation

    Ventilation per minute

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

  14. Tidal volume

    Tidal volume in liters

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

  15. Ventilatory reserve

    Defined as maximal voluntary ventilation (MVV) - VE

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

06

Study locations

1 of 2 sites recruiting
  • Blekinge Institute of Technology
    Karlskrona, Blekinge County, Sweden
    Not yet recruiting
  • Lund University hospital and Region Skåne
    Lund, Sweden
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07500974
Lead sponsor
Region Skane
Collaborators
Blekinge Institute of Technology, Blekingesjukhuset, Karlskrona
Responsible party
Sponsor
First posted
Mar 30, 2026
Start date
May 7, 2026
Primary completion
Apr 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Zainab Ahmadi, MD, PhD
Contact
zainab.ahmadi@med.lu.se
046171000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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